A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- the change of disease activity (SLEDAI score)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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);
- •No more than three types of combined classic IS or biological agents, not including HCQ.
- •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.
排除标准
- •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.
研究组 & 干预措施
Sulfasalazine group
干预措施: Sulfasalazine Tablets (Drug)
结局指标
主要结局
the change of disease activity (SLEDAI score)
时间窗: 16 weeks
reaching the SLEDAI score based on clinical symptoms and laboratory tests according to the SLEDAI score system
次要结局
- the number of patients who can reach SRI-4(16 weeks)
- the change of prednisone dosage(16 weeks)
研究者
Qiong Fu
Clinical professor
RenJi Hospital