systemic lupus erythematosus
Conditions
Interventions
Experimental group:iguratimod
Sponsors
the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 18, male or female 2. According to the 2012 SLICC standard, SLE was diagnosed 3.Active disease: 5 = 30 days 5. I have not used Elamod in the past 30 days 6. Weight not less than 40kg 7. Agree to use effective contraception during the study period and one month before and after the study 8. Agree to sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Severe active lupus nephritis and severe lupus nephritis 1.1 Proteinuria>3g/24h or equivalent 1.2 Serum creatinine>2.5mg/dL 1.3 Hemodialysis is required due to lupus nephritis 1.4 Glucocorticoid dosage>1mg/kg/day (prednisone dosage or equivalent hormone dosage) 2. Severe active CNS lupus: Any of the following CNS lupus symptoms has ever occurred, regardless of whether the symptoms existed at the time of enrollment: epileptic seizure, insanity, organic brain syndrome, CVA, encephalitis or CNS vasculitis 3. Associated with other autoimmune diseases, such as rheumatoid arthritis, Sjogren's syndrome, myositis, scleroderma, autoimmune liver disease, Hashimoto's thyroiditis, etc 4. Have a history of gastrointestinal bleeding disease, and only diagnosed active gastrointestinal ulcer in one year 5. Serious complications: including heart failure (= Grade III NYHA), respiratory failure, renal insufficiency (creatinine clearance rate = 30ml/min), liver insufficiency (ALS or AST = twice the upper limit of normal range), and severe hypertension 6. Have acute severe infection: such as septicemia and cellulitis, hepatitis B or C virus infection virus replication period, active period of mycobacterium tuberculosis infection, human immunodeficiency virus (HIV) 7. Have used biological agents or small molecule targeted drugs; Have received plasma exchange, blood adsorption, hemodialysis, mesenchymal stem cell transplantation and other treatments 8. Inject live vaccine or attenuated live vaccine within 4 weeks before screening 9. Warfarin or other anticoagulants were used within 14 days before screening; Long term use of warfarin due to control of other diseases 10. There are serious peripheral blood abnormalities (WBC<3) caused by non lupus × 109/L or PLT < 50 × 109/L or HGB<85g/L) 11. Patients with a history of malignant tumor, excluding healed, carcinoma in situ and basal cell carcinoma 12. Pregnant women and lactating women 13.2 History of alcoholism within a year 14. Participation in other clinical trials during screening 15. The researcher considers it inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systemic lupus erythematosus (sle) response index;score of Systemic lupus erythematosus disease activity index 2000((SLEDAI-2K);The British Isles Lu Assessment Group -2004; | — |
Secondary
| Measure | Time frame |
|---|---|
| T lymphocyte and B lymphocyte cells count;immunoglobulin; | — |
Countries
China
Contacts
Public ContactMing Gui
the Third Xiangya Hospital of Central South University
Outcome results
None listed