Systemic lupus erythematosus in children
Conditions
Interventions
Study Group:Telitacicept
Sponsors
Beijing Children's Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Children diagnosed with systemic lupus erythematosus SLE according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria; ANA titer 1:80 or higher; 2. Children aged 8 years (inclusive) to 18 (inclusive); body weight more than 30kg; 3. Patients who have received standard therapy or biologics in the past and whose disease activity is not adequately controlled (SLEDAI > 8 points); 4. Relapse (>=1 relapse) or new organ involvement after previous standard therapy and/or Beliu treatment; 5. Currently receiving CS and/or antimalarial therapy and/or other disease-modifying antirheumatic drugs (DMARDs) as specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Active viral, bacterial or other infection requiring systemic treatment at screening or randomization, or a history of clinically significant recurrent infection; 2. Chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV); 3. Evidence of active tuberculosis infection; 4. History of primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) test results at screening Patients with severe activity (combined with lupus brain, macrophage activation, TMA, pulmonary hemorrhage, or SLEDAI score>). 30 points ; 5. B-cell count below the lower limit of normal or baseline (whichever is lower) before receiving B-cell depleting therapy; 6. Any of the following abnormal laboratory values at screening: (1) Platelets < 25000/mm^3 (< 25 × 10^3 /µL); (2) Hemoglobin (Hgb) < 8.0 g/dL (< 5 mmol/L), or < 7.0 g/dL (< 4.3 mmol/L); If it is related to the subject's systemic lupus erythematosus, such as active hemolytic anemia); (3) Absolute neutrophil count (ANC) < 0.8 × 10^3 /µL; 7. Those who have previously used tetacept therapeutic drugs; 8. Received live/attenuated vaccines within 4 weeks before the first dose; 9. Children who are allergic to the study drug; 10. Unable to complete regular follow-up of children; 11. Any surgical, medical, mental or other physical condition that may affect this study; 12. Severe organ dysfunction or life-threatening diseases, such as severe patients with MAS or TMA, lupus encephalopathy, severe thrombocytopenia, etc.; 13. Those who have received B-cell targeted drugs or other types of biologics within 3 months; Patients who received IVIG or methylprednisolone shock within 14.4 weeks; 15. Any uncontrolled co-existing serious illness, such as uncontrolled hypertension, heart failure, type I diabetes, thyroid disease within 3 months prior to the first dose, or significant non-regressing disease within 2 weeks prior to the first dose that, in the opinion of the investigator, may put the subject at risk when participating in the study or interfere with the evaluation of the subject's SLE-related symptoms; 16. Any surgical, medical, psychiatric, or other physical condition that, in the opinion of the investigator, may cause potential harm to the subject from participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SRI-4 response; | — |
Countries
China
Contacts
Public ContactDeng Jianghong
Beijing Children's Hospital affiliated to Capital Medical University
Outcome results
None listed