Systemic lupus erythematosus
Conditions
Interventions
Research group :Glucocorticoids, hydroxychloroquine sulfate, total glucosides of paeony
Control group:Glucocorticoids, hydroxychloroquine sulfate
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Individuals aged 18-65 with independent mobility, regardless of gender; 2) SLE patients diagnosed according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE classification criteria; 3) SLE patients with mild activity in accordance with the 2020 Chinese Guidelines for the Diagnosis and Treatment of Systemic Lupus Erythematosus (SLEDAI-2000 <= 6 points); 4) Patients with new diagnosis, or those who have previously been diagnosed with medication but have been washed out before screening (the washing out period of common immunosuppressants and biologics is shown in the table below), and can be regularly followed up; generic name Wash off period before screening Cyclophosphamide 180 days Methotrexate 30 days mycophenolate mofetil 30 days Cyclosporine 30 days Thalidomide 60 days JAK inhibitor 28 days Abatacept days Taitasip 60 days Belimumab 65 days Rituximab 12 months Intravenous immunoglobulin injection 28 days 5) From the screening period until the end of the last administration, being able to take effective contraceptive measures (any of the following): Intrauterine device; Oral contraceptive pills; condom. 6) Understand and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Individuals who are allergic or contraindicated to all medications or their components used in this experiment; 2) Individuals with significant organ involvement, such as severe liver dysfunction (ALT>2 times the upper limit of the normal range), renal dysfunction (eGFR <= 90ml/min), neuropsychiatric lupus, pulmonary involvement, and cardiac involvement; 3) Patients with white blood cell count less than 2.0 × 10^9/L, or with clear anemia (hemoglobin less than 80g/L), or platelet count less than 60 × 10^9/L, or with other blood system diseases; 4) Patients with severe cardiovascular and cerebrovascular diseases, respiratory system diseases, blood and endocrine disorders, as well as malignant tumors; 5) Infections such as pneumonia and mold; 6) Individuals with a history of eye surgery and those suffering from eye diseases such as retinopathy; 7) Individuals with mental illness or intellectual disabilities who cannot accurately describe their own feelings or record medication use; 8) History of active gastrointestinal bleeding or ulcers within the past year; 9) Accompanied by other autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, etc; 10) History of alcohol, drug or substance abuse within the past year; 11) Received attenuated live vaccine within 3 months before entering the clinical study, or prepared to receive the vaccine during the study period; 12) Those who have used other immunosuppressants or biologics in combination within the past 30 days; 13) Individuals who have participated in clinical trials of other drugs within 30 days prior to screening; 14) Pregnant or lactating women; 15) The researchers determined that the patients were not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number and proportion of patients with low disease activity status (LLDAS) at week 24;The number and proportion of patients who have been in LLDAS status for more than 3 months;Time to reach LLDAS;Changes in SLE Disease Activity SLEDAI-2000 at each follow up points; | — |
Secondary
| Measure | Time frame |
|---|---|
| Systemic lupus erythematosus disease activity SLEDAI-2000 at each follow-up point;The number and proportion of low disease activity status (LLDAS) patients at each follow-up point;Disease response rate (DORIS) at each follow-up point (four categories);Time to DORIS at each follow-up point;SystemicLupusInternational CollaboratingClinics/American College of Rheumatology (SLICC/ACR) damage index (SDI)at each follow-up point;The proportion of new organ damage at each follow-up point;The proportion of gradually decreasing glucocorticoid doses to 7.5mg/day at each follow-up point; Glucocorticoids reduction at each follow-up point (percentage reduction compared to baseline);Average daily dosage of glucocorticoids during the study period;Glucocorticoids withdrawal time at each follow-up point;Recurrence rate at each follow-up point;The proportion of patients with increased glucocorticoids dosage and/or additional immunosuppressive agents at each follow-up point due to disease progression;Self-regulating fatigue scale at each follow-up point;Antinuclear antibodies and titers at 0w, 4w, 12w, and 24w;Anti double stranded DNA and titers at 0w, 4w, 12w, and 24w;Immunoglobulin (IgA/G/M) at 0w, 4w, 12w, and 24w;Complement C3/C4 at each follow-up point;24-hour urinary protein at each follow-up point;Urine protein/creatinine ratio at 0w, 4w, 12w, and 24w;ESR at 0w, 4w, 12w, and 24w;C-reactive protein at 0w, 4w, 12w, and 24w;Serum levels of TNF - a, IL-4, IL-6, IL-10, IL-8, and interferon - ? (IFN - ?) at 0w, 4w, 12w, and 24w;Adverse events and incidence rates at each follow-up poin;Infection incidence rate; | — |
Countries
China
Contacts
Public ContactLi Sun
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed