Patients with systemic lupus erythematosus
Conditions
Interventions
Iguratimod Treatment Group :None
Standard treatment+Iguratimod Treatment Group :None
Sponsors
Guangzhou Panyu District Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. SLE was diagnosed according to ACR criteria. 3. Active SLE, SLEDAI>=4. 4. Subjects with positive antinuclear antibody (ANA) or anti-double-stranded DNA (DNA) serum antibody test; 5. Stable SLE treatment; 6. Subjects agreed to receive iguratimod as part of the treatment regimen during the study, and signed a fully informed informed consent form; 7. Patients with written informed consent.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women. 2.Treatment with any biologic investigational drug within the past year. 3.Severe infection requiring hospitalization or medical intervention within the last 4 weeks. 4.Current drug or alcohol abuse/dependence. 5.History of or positive screening test for HIV, hepatitis B (HBV), or hepatitis C (HCV). 6.Severe cardiovascular, cerebrovascular, or life-threatening comorbidities, including: ? Known malignancy (active cancer). ? Myocardial infarction, unstable angina, stroke, or transient ischemic attack (TIA) within the past 6 months. ? Refractory hypertension. 7.Patients unlikely to comply with follow-up or complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving Lupus Low Disease Activity State (LLDAS) at Week 24.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in SLEDAI-2000 score from baseline to Week 24;Proportion of patients achieving DORIS remission at Week 24;The changes of EQ-5D-5L score and SF-36 score;Serological index changes from baseline: anti-dsDNA, complement C3, C4 levels, immunoglobulin IgG, IgA, IgM levels;Organ Damage Index Assessment (SDI score);Recurrence situation (time of first recurrence, number of recurrences, recurrence rate);The changes in B cell subsets compared to the baseline and their correlation with disease activity;Changes in 24-hour proteinuria or UPCR compared to baseline;The proportion of patients achieving renal remission;Observe the improvement of platelet count in patients with platelet count <50×10^9/L at baseline after treatment; | — |
Countries
China
Contacts
Public ContactXie Zhengquan
Guangzhou Panyu District Hospital of Traditional Chinese Medicine
Outcome results
None listed