Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus, Sulfasalazine, interferon
Brief summary
The goal of this clinical trial is to learn if sulfasalazine is safe and feasible in the treatment of active lupus erythematosus (SLE). The main questions it aims to answer are: Does drug sulfasalazine with stable background treatment help lower the disease activity (SLEDAI) at week 16? How many patients can reach SRI-4 at week 16? Can this regimen help lower the prednisone dosage the patients need at week 16? What about the change of the type I interferon related genes expression at week 16? Participants will: Take sulfasalazine 750mg/dose, twice a day for 16 weeks. The dosage will be increased to 1000mg/dose within one month, twice a day if the patient could tolerate. Visit the clinic once every 4 weeks for checkups and tests.
Interventions
DRUGSulfasalazine Tablets
All subjects who meet the inclusion/exclusion criteria will be given sulfasalazine 750mg/dose, twice a day. The dosage will be increased to 1000mg/dose within one month, twice a day if the patient tolerates well.
Sponsors
Qiong Fu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of SLE according to the 2012 SLICC SLE classification criteria. * 18 to 65 years old, regardless of gender. * Active SLE, i.e. SLEDAI-2K score ≥ 4 points at enrollment. * Receiving standard of care: 1. Prednisone dosage≤20mg/day, with or without hydroxychloroquine (HCQ,≤400mg/day), classic immunosuppressive agents (IS),ie, mycophenolate mofetil(≤2.0g/day), azathioprine (≤2mg/kg/day), cyclosporine(≤5.0mg/kg/day), tacrolimus(≤3.0mg/day), methotrexate(≤20mg/week), leflunomide(≤40mg/day), or biological agents such as belimumab(≤ 10mg/kg/month) and telitacicept (≤160mg/week); 2. No more than three types of combined classic IS or biological agents, not including HCQ. 3. Prednisone dosage should NOT be increased within one month of the screening period, and the immunosuppressants regimen should be stable for at least one month. * Agree to sign the informed consent form. * Agree to receive contraception through intrauterine devices or oral contraceptives (progesterone or compound progesterone) or condoms.
Exclusion criteria
* Severely active SLE: SLEDAI-2K \>12 at screening. * 24-hour urine protein≥ 3g/24 hours. * eGFR \< 60mL/min/1.73m2 (EPI formula). * Baseline prednisone dosage\>40mg/d at screening. * Other autoimmune diseases, such as rheumatoid arthritis, Sjogren's syndrome, myositis, scleroderma, autoimmune liver disease, etc. * Leukopenia or thrombocytopenia (WBC≤3×109/L or PLT≤50×109/L) not caused by SLE. * Liver dysfunction (ALT or AST more than twice the normal upper limit). * Allergic to sulfonamide drugs. * Pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change of disease activity (SLEDAI score) | 16 weeks | reaching the SLEDAI score based on clinical symptoms and laboratory tests according to the SLEDAI score system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the number of patients who can reach SRI-4 | 16 weeks | SRI-4 is defined as: 1.the SELENA-SLEDAI score decreased by ≥ 4 points compared to baseline, and there were no new BILAG grade A or ≤ 2 new BILAG grade B compared to baseline, and the overall physician assessment (PGA) did not deteriorate (an increase of\<0.30 points from baseline) |
| the change of prednisone dosage | 16 weeks | baseline prednisone dosage subtracts the prednisone dosage at week 16. |
Other
| Measure | Time frame | Description |
|---|---|---|
| the change of interferon stimulating genes (ISG) expression | 16 weeks | the ISG level at baseline subtracts the ISG level at week 4, week 8, week 12 and week 16. |
Contacts
Primary Contactqiong Fu
Outcome results
None listed