systemic lupus erythematosus
Conditions
Interventions
NHMX:One kind of non-steroid anti-inflammatory drugs combines with hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine (m
control:hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine(maintaining the drug concentration between 30-90ug/l)
Sponsors
The Third Affiliated Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects with SLE meet the American College of Rheumatology (ACR) standard, 1997; 2. Subjects who have a screening SLEDAI-2K score >=5; 3. Aged 18 to 65 years; 4. Signed the informed consent.
Exclusion criteria
Exclusion criteria: Significant allergies to anti-malarials, NSAIDs, corticosteroids, cyclophosphamides, methotrexates, ciclosporins; Sever chronic liver, kidney dysfunction; Women who are pregnant or breast feeding; Other clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease,hematological system diseases etc.); Combination with other autoimmune diseases; Exposure to biological agents 12 months prior to enrollment Exposure to Methotrexate Hydroxychloroquine 3 months prior to enrollment Participation in another study with investigational drug within 8 weeks preceding the present study; Patients with mental disorder; Patients with active hemorrhage and digestive tract ulcer; History of visual interference or cataract patients; Chronic infections: HIV-positive individuals (increased risk of severe infections); Patients suffering from active hepatitis B or C are ineligible; Patients suffering from active tuberculosis are ineligible; History of cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SLE responder index-4; | — |
Secondary
| Measure | Time frame |
|---|---|
| SLEDAI Score; | — |
Countries
China
Contacts
Public ContactErwei Sun
Department of Rheumatology and Immunology, The Third Affiliated Hospital, Southern Medical University
Outcome results
None listed