A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-RD
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Recurrence rate at 52 weeks
研究概览
简要总结
For patients with active proliferative IgG4-RD, we plan to conduct a 52-week prospective randomized controlled trial to compare the efficacy and safety of 5mg lenalidomide plus prednisone, 10mg lenalidomide plus prednisone, and prednisone alone, so as to find new treatment measures for patients with proliferative IgG4-RD.
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
- •Patients aged between 18 and 75 years who meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for IgG4-RD；
- •Patients with active disease: For patients with initial treatment or relapse after drug withdrawal, active disease is defined as having an IgG4-RD Response Index (RI) of at least 2 points in at least one organ at the time of screening; for those experiencing relapse while on treatment, active disease is defined as having an IgG4-RD RI of at least 3 points in at least one organ at the time of screening；
- •Patients with the clinical subtype of proliferative IgG4-RD；
- •Patients who have no plans for pregnancy within the next 18 months and who agree to use reliable contraceptive measures during the study period；
排除标准
- •IgG4-RD patients with only fibrotic features;
- •Absolute neutrophil count <1.5×10^9 /L or platelet count <100×10^9/L;
- •Creatinine clearance less than 60 ml/ min;
- •Liver function Child-Pugh grade B or above;
- •Chronic active infection requiring systemic treatment;
- •Diagnosed with malignant tumor in the past five years;
- •Patients with a history of thrombosis;
- •Using biological agents within six months;
- •Known to be allergic to lenalidomide or thalidomide;
- •Pregnant or lactating women;
- •Patients with any other medical conditions or for specific reasons judged by the investigator to be ineligible to participate in the study.
研究组 & 干预措施
5mg lenalidomide group
Lenalidomide 5mg/d combined with prednisone, prednisone at an initial dose of 0.6-0.8mg/kg/d for 2-4 weeks, then reduced by 5mg every 1-2 weeks until discontinued (within 24 weeks)
干预措施: 5mg lenalidomide (Drug)
10 mg lenalidomide group
Lenalidomide 10mg/ day combined with prednisone, the initial dose of prednisone was 0.6-0.8mg/kg/ day for 2-4 weeks, then 5mg every 1-2 weeks until withdrawal (within 24 weeks).
干预措施: 10mg lenalidomide (Drug)
Prednisone monotherapy group
The initial dose of prednisone was 0.6-0.8mg/kg/ day for 2-4 weeks, followed by 5mg every 1-2 weeks until withdrawal (within 24 weeks).
干预措施: Prednisone monotherapy (Drug)
结局指标
主要结局
Recurrence rate at 52 weeks
时间窗: "From enrollment to the end of treatment at 52 weeks
次要结局
- IgG4 - RD RI change(At 4, 12, 24, 36, 52 weeks)
- Treatment response rate(At 4, 12, 24, 36, 52 weeks)
- Change of IgG4-RD damage index (DI)(At 4, 12, 24, 36, 52 weeks)
- security(At 4, 12, 24, 36, 52 weeks)
- physician's overall assessment of disease activity(At 4, 12, 24, 36, 52 weeks)
- Changes of serum IgG4 levels(At 4, 12, 24, 36, 52 weeks)
研究者
Wen Zhang
Vice director of rheumatology department
Peking Union Medical College Hospital