Clinical Study on the Efficacy and Safety of Tofatib and Cyclophosphamide in the Treatment of Active IgG4 Related Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Disease remission rate at 1 month, 3 months and 6 months of treatment (%)
研究概览
简要总结
Compared with cyclophosphamide, the efficacy and safety of tofacitinib in the treatment of active IgG4-related diseases were evaluated.
详细描述
This study is a prospective, single center, non randomized, controlled, open label clinical observation study to evaluate the efficacy and safety of tropitib versus cyclophosphamide in inducing remission in IgG4-RD patients.
- Investigators observe the diagnosis and treatment of IgG4-RD patients, and only provide patients with clinically appropriate diagnosis and treatment proposals.
It does not interfere with the choice of treatment plan for patients with the study drug of tropib or cyclophosphamide. If the patient chooses the hormone combined with tofatib or the hormone combined with cyclophosphamide as the main treatment drug, and at the same time meets the inclusion and exclusion criteria of this study, the patient can be included in this clinical observation study and become a subject. The experimental group was treated with glucocorticoid combined with tofatib, and the control group was treated with glucocorticoid combined with cyclophosphamide. It is planned that 20 people in each group will be treated for 6 months. After the study, the number of subjects in each group shall be at least 20 according to the actual situation. In the final statistical analysis, ensure that the sample size of the two groups participating in the statistical analysis is controlled at about 1:1.
- The primary end point of this study was to compare the remission rate of the two groups after treatment; The secondary end point was to compare the response rate, recurrence rate and adverse event rate of the two groups after treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •It meets the 2019 ACR/EULAR classification diagnostic criteria for IgG4 related diseases, and is an active IgG4-RD, defined as an IgG4-RD RI score ≥ 3 points when screening
排除标准
- •IgG4 related diseases endangering organ function or life;
- •Only Mikulicz disease, no other internal organs involved;
- •People with history of thrombotic disease or high risk of thrombosis;
- •Have a history of malignant tumor;
- •Active infection;
- •Pregnant or lactating women;
研究组 & 干预措施
Glucocorticosteroids combined with Cyclophosphamide Group
Glucocorticoid: 0.5-1.0 mg/kg/d prednisone (or other glucocorticoids of equivalent dose) for 1 month (visit V2-V3), then reduced by 5 mg every 2 weeks, and maintained at 5-10 mg/day to visit V8.
Cyclophosphamide: intravenous infusion, once a month, 0.5-1g/m2 each time, 6 times in total, until the end of visit V7.
干预措施: tofacitinib (Drug)
Glucocorticoids combined with tofacitinib Group
Glucocorticoid: 0.5-1.0 mg/kg/d prednisone (or other glucocorticoids of equivalent dose) for 1 month (visit V2-V3), then reduced by 5 mg every 2 weeks, and maintained at 5-10 mg/day to visit V8.
Tofacitinib: oral, twice a day, 5mg each time, lasting for 6 months, until the end of visit V8.
干预措施: tofacitinib (Drug)
结局指标
主要结局
Disease remission rate at 1 month, 3 months and 6 months of treatment (%)
时间窗: 1 month, 3 months and 6 months of treatment
Definition of disease remission: including ① complete remission (CR) (main efficacy index), partial remission (PR), continuous complete remission (CCR) and no change (NC).
次要结局
- Changes in physician's overall assessment (PGA) from baseline at 1 month, 3 months and 6 months of treatment(1 month, 3 months and 6 months of treatment)
- Response rate at 1 month, 3 months and 6 months after treatment (%)(1 month, 3 months and 6 months after treatment)
- Disease recurrence rate at 3 and 6 months after treatment (%)(3 and 6 months after treatment)