Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The difference of relapse rate of IgG4-RD among 3 groups in 12 months.
研究概览
简要总结
This study has been designed as a 12-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of three treatment strategies in IgG4-RD patients with superficial organ involvement: Diprospan plus iguratimod, Diprospan plus leflunomide and prednisone plus leflunomide.
详细描述
90 IgG4-RD patients with superficial organ involvement are enrolled in this study and randomly divided into three groups at a 1:1:1 ratio: patients in group I are treated with Diprospan (1mL im) and then with iguratimod (25mg bid); patients in group Ⅱ are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd); and patients in group Ⅲ are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg qd). All patients will be followed up for 12 months, and clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded during follow up. The primary endpoint is the difference of relapse rate between two groups at 12 months. The secondary endpoints are relapse time, response rate and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria;
- •Newly-onset or relapsed patients who requires initiation or continuation of glucocorticoids treatment;
- •The addition of glucocorticoids was started at lower than 10 mg/d.
排除标准
- •Patients who were diagnosed as other autoimmune diseases;
- •Patients who were diagnosed as malignant diseases;
- •Pregnant and lactating women；
- •Active infection: HIV, HCV, HBV, TB；
- •Severe irreversible damage of organ function;
- •Receipt of any biologic therapy or immunosuppressive agent other than GCs.
研究组 & 干预措施
Group I
Patients are treated with Diprospan (1mL im) and then with iguratimod (25mg bid) for 12 months
干预措施: Diprospan plus iguratimod (Drug)
Group II
Patients are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd) for 12 months.
干预措施: Diprospan plus leflunomide (Drug)
Group Ⅲ
Patients are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg qd) for 12 months.
干预措施: Prednisone plus leflunomide (Drug)
结局指标
主要结局
The difference of relapse rate of IgG4-RD among 3 groups in 12 months.
时间窗: 12 months
The definition of relapse: elevation of IgG4-RD Responder Index ≥ 2 points; new organ involvement or recurrence, with or without elevation of serum IgG4 levels.
次要结局
- The difference of the time at baseline to first relapse among 3 groups(12 months)
- Side effects(12 months)
- The difference of the response rate of the treatment among the 3 groups.(12 months)
研究者
Wen Zhang
Professor
Peking Union Medical College Hospital