治験レーダー

Participants meeting any of the following criteria will be excluded:

1. Central nervous system disease: active or unstable lupus-related neuropsychiatric disease within 60 days, including epilepsy, confusion, cerebrovascular events, etc.;
2. Acute severe nephritis: renal replacement therapy within 3 months before the screening period or ongoing, or significant kidney disease that, in the opinion of the investigator, may occur and lead to the need for high-dose glucocorticoid (prednisone dose ≥ 2 mg/kg/d or equivalent of other hormones), cyclophosphamide or escalated MMF treatment within the first 3 months of the study;
3. Severe antiphospholipid syndrome within 12 months before or during screening；
4. Congenital heart disease or a history of acute myocardial infarction within 6 months before screening, or severe arrhythmia (including polymorphic ventricular tachycardia, ventricular tachycardia, etc.); or combined with moderate to large pericardial effusion, severe myocarditis, etc.; or unstable vital signs, patients who need blood pressure-raising drugs to maintain blood pressure;
5. Suffering from other diseases that require long-term administration of glucocorticoids or immunosuppressive agents;
6. Having active infections or uncontrollable infections that require systemic treatment within one week before screening;
7. Having received solid organ transplantation or hematopoietic stem cell transplantation within three months before screening; or having grade 2 or higher acute graft-versus-host disease (GVHD) within two weeks before screening;
8. History of severe recurrent or chronic infections, especially recurrent or chronic infections associated with respiratory problems.
9. Immunoglobulin G levels below the lower limit (5-8 years: <4.5 g/L, 9 years and older: <6.0 g/L);
10. History of hepatitis B virus (HBV) infection or positive serology indicating current or past HBV infection. Human immunodeficiency virus (HIV; positive HIV antibody test) and active hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid \[RNA\]). Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection;
11. A history of tuberculosis or active tuberculosis; or latent tuberculosis treated before the baseline; or subjects with an indeterminate test result who screened positive for PPD or T-spot can be retested, but if the repeat test is also indeterminate, they are excluded;
12. Had a history of macrophage activation syndrome within 1 month prior to screening;
13. Had received any anti-CD19 or anti-CD20 therapy, such as rituximab, obinutuzumab, ocrelizumab, or ofatumumab, within 3 months prior to screening or during screening;
14. Received a JAK inhibitor, Bruton tyrosine kinase (BTK) inhibitor, or tyrosine kinase 2 (TYK2) inhibitor, such as baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or zanubrutinib and Fenebrutinib, during screening;
15. Treatment with cyclophosphamide or a biologic agent within 4 weeks prior to enrollment, including but not limited to adalimumab, etanercept, golimumab, infliximab, Infliximab), Belimumab, Ustekinumab, Anifrolumab, Secukinumab, or Atacicept;
16. Intolerance or contraindication to the investigational therapy, including a history of severe allergies or allergic reactions to monoclonal antibodies, or a known hypersensitivity to any of the ingredients in belimumab injection;
17. Live vaccine within 4 weeks prior to screening;
18. Positive blood pregnancy test;
19. Patients with known malignant diseases such as tumors before screening;
20. Patients who have participated in other clinical trials within 3 months prior to enrollment;
21. Patients with depression or suicidal tendencies;
22. Other situations where the investigator believes the patient is not suitable for participation in the study.