Systemic lupus erythematosus
Conditions
Interventions
Telitacicept group :Tagitacept in combination with glucocorticoids and calcineurin inhibitors
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-65 years old, male or female; (2) Patients with a definite diagnosis of SLE, that is, those who meet at least 4 of the 11 classification criteria of SLE as revised by the American College of Rheumatology in 1997 or the 2019 EULAR criteria or the 2012 SLICC criteria; (3) Patients who have not responded to regular glucocorticoid and CNI treatment for at least 3 months; (4) Platelet count <50×10^9/L;
Exclusion criteria
Exclusion criteria: (1) thrombocytopenia caused by other causes such as drug-induced and primary blood diseases; (2) thrombocytopenia secondary to other autoimmune diseases; (3) Hepatitis B or cirrhosis of the liver, HIV infection, active tuberculosis infection, active systemic infection, a definite diagnosis of serious infectious diseases (such as sepsis, etc.); (4) Patients with severe visual or hearing impairment, or dementia, serious mental disorders and mental illnesses, and patients with a history of mental illness; (5) Patients with malignant tumors, complicated with serious heart, lung, liver and kidney diseases; (6) Women who are pregnant or planning to become pregnant in the near future, breastfeeding women; (7) Patients who received CD20 MAB, Belimumab, TNF-alpha mab/fusion protein, and JAK kinase inhibitors within 6 months before screening; (8) Allergic to Telitacicept; (9) Patients who received live vaccine within the last month; (10) Patients who are participating in clinical studies of other drugs; (11) Patients with no regular follow-up; (12) The investigator determines that there are reasons for not participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet count level; | — |
Secondary
| Measure | Time frame |
|---|---|
| SLEDAI-2000 score;hemoglobin;White blood cell count level; | — |
Countries
China
Contacts
Public ContactChe Nan
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed