Systemic lupus erythematosus
Conditions
Interventions
Experimental group:Norcantharidin combined with standard treatment
Control group:Standard treatment consisting of glucocorticoids, hydroxychloroquine and immunosuppressants
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age =18 years old.2) Systemic lupus erythematosus was clinically diagnosed according to the 1977 criteria of the American College of Rheumatology (ACR). 3) Voluntarily participate in the study and sign the informed consent. If the subject is unable to read and sign the informed consent due to incapacity or other reasons, the guardian is required to inform the process and sign the informed consent. If the subject does not have the ability to read the informed consent (e.g., illiterate subjects), a witness must witness the informed process and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Neuropsychiatric lupus. 2) Patients who had received B-cell targeted therapy within 1 year before baseline. 3) Lactating women. 4) Those who have received therapeutic drugs of unknown composition in the past 28 days. 5) People who are allergic to norcantharidin. 6) Active infected persons have been present in the past 28 days. 7) History of malignant tumor in recent 5 years.8) People with serious liver and kidney diseases, cardiovascular and cerebrovascular diseases, respiratory diseases, and blood and endocrine diseases. 9) Vulnerable groups, including people with mental illness, people with cognitive impairment, critically ill patients, pregnant women, etc.10) The researcher believes that the subjects are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of systemic lupus erythematosus SRI-4(SLE response index 4) at week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of SLE activity related indexes;Glucocorticoid reduction (percentage reduction compared to baseline period);Adverse events;Changes of T cell and B cell subsets;Cytokine change; | — |
Countries
China
Contacts
Public ContactYongmei Han
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed