A Randomized Open Label Clinical Study on the Efficacy of Tofacitinib in the Treatment of IgG4 Related Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- IgG4-RD remission rate
研究概览
简要总结
This study is a single centre, open label, randomized controlled study to compare the efficacy and safety between steroids plus tofacitinib and steroids alone in active IgG4-related diseases patients. It is expected to enroll a total of 58 IgG4 RD patients. The sample size of two groups is 1:1.
The primary end points of this study is to compare the IgG4-RD response rate between two groups at 24 weeks.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 ≤ Age ≤ 70 years old;
- •Complies with the 2019 ACR/EULAR IgG4 RD classification criteria
- •Patients with initial or recurrent active IgG4 RD (IgG4 RD RI ≥ 3 points).
- •Voluntary signing of informed consent: Patients must be given a written consent form when participating in the trial, and it is hoped that patients can comply with the requirements of the study follow-up plan and other protocols;
- •Female participants of childbearing age agreed to use effective contraceptive measures during the study period.
排除标准
- •Participants in other trials or those who have participated in clinical trials of other drugs within 2 months;
- •Individuals who have received live vaccine immunization within 2 weeks prior to enrollment, or who require live vaccine immunization during the trial period;
- •Merge other autoimmune diseases
- •Active infected individuals need to be excluded. Latent tuberculosis requires prevention with isoniazid 0.3g/d one month in advance; People with hepatitis B HBsAg+and HBV-DNA negative need to take anti hepatitis B virus drugs one month in advance.
- •Pregnant and lactating women, or women of childbearing age who have fertility requirements during the study period and within 6 months after the last dose of medication;
- •Patients with a history of thromboembolism, or severe diseases such as coronary heart disease and other important organs such as the heart, brain, liver, lung, kidney, and hematopoietic system, malignant tumors, and psychiatric disorders;
- •Other researchers believe that it is not suitable for enrollment.
研究组 & 干预措施
steroids plus tofacitinib
Prednisone (or equivalent drug) 0.6mg/kg/d orally. When the calculated values of two groups of prednisone are not multiples of 5, the dose of prednisone less than 5mg is rounded off. The initial dose should not exceed 60mg/day. If it exceeds 60mg/day, the medication should be administered at a rate of 60mg/day. Reduce the dosage by 5 mg every 2 weeks until reaching the maintenance dose of 5 mg/d.
Tofacitinib: 5mg,bid
干预措施: Tofacitinib 5mg Oral Tablet (Drug)
steroids plus tofacitinib
Prednisone (or equivalent drug) 0.6mg/kg/d orally. When the calculated values of two groups of prednisone are not multiples of 5, the dose of prednisone less than 5mg is rounded off. The initial dose should not exceed 60mg/day. If it exceeds 60mg/day, the medication should be administered at a rate of 60mg/day. Reduce the dosage by 5 mg every 2 weeks until reaching the maintenance dose of 5 mg/d.
Tofacitinib: 5mg,bid
干预措施: Prednisone 5mg (Drug)
steroids alone
Prednisone (or equivalent drug) 0.6mg/kg/d orally. When the calculated values of two groups of prednisone are not multiples of 5, the dose of prednisone less than 5mg is rounded off. The initial dose should not exceed 60mg/day. If it exceeds 60mg/day, the medication should be administered at a rate of 60mg/day. Reduce the dosage by 5 mg every 2 weeks until reaching the maintenance dose of 5 mg/d.
干预措施: Prednisone 5mg (Drug)
结局指标
主要结局
IgG4-RD remission rate
时间窗: 24 week
Evaluate treatment response by assessing changes in the IgG4 RD RI score and categorize it into three types: complete response (CR), partial response (PR), and no effect (NE, including no improvement or deterioration). IgG4 RD RI score\<3 and a decrease of ≥ 2 is considered CR; A decrease of ≥ 2 in IgG4 RD RI score but a maintenance of ≥ 3 is considered PR. If the patient's IgG4 RD RI score is initially 3 points, a decrease of 1 point after treatment is considered PR. Patients with no significant changes in tumor size and/or clinical presentation and a decrease in IgG4 RD RI score\<2 are considered NE.
次要结局
- recurrence rate(24 week)
- serum IgG4(24 week)
- rate of adverse events(24 week)
研究者
Ye Hua
Professor
Peking University People's Hospital