A Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Relapse rate at 12 months.
研究概览
简要总结
The study has been designed as a 12-month, open-label, randomized, controlled study comparing the use of prednisone mono-therapy and prednisone and leflunomide combination therapy in treating patients with IgG4-related disease.
详细描述
The aim of this clinical trial is to determine the safety and efficacy of Leflunomide in treating patients with IgG4-related disease by comparing the outcomes of prednisone and leflunomide combination therapy with prednisone mono-therapy. The follow-up period will be 12 months. During the follow-up period, results of laboratory tests and image examinations, IgG4-RD RI and other parameters which can reflect treatment response as well as adverse effect events will be recorded.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years.
- •Diagnosis of IgG4-RD according to either Consensus statement on the pathology of IgG4-related disease (for those who have undergone biopsies) or 2011 Comprehensive diagnostic criteria for IgG4-related disease. Both of the two criteria for diagnosis are specified below.
- •(1)Consensus statement on the pathology of IgG4-related disease
- •Histopathologic features consisting of dense lymphoplasmacytic infiltrate, fibrosis(usually storiform in character)and/or obliterative phlebitis within involved organs.
- •Either an elevated IgG4+/IgG+cell ratio of >40% within the affected organs or elevated IgG4-bearing plasma cells per high-power field is necessary. The cut-off number of IgG4-bearing plasma cells per high-power field is different depending upon the types of affected organs and specimens(through surgery or needle puncture biopsy).
- •(2)2011 Comprehensive diagnostic criteria for IgG4-related disease
- •Clinical examination showing characteristic diffuse/localized swelling or masses in single or multiple organs.
- •Hematological examination shows elevated serum IgG4 concentrations(135 mg/dl).
- •Histopathologic examination shows marked lymphocyte and plasmacyte infiltration and fibrosis or Infiltration of IgG4+ plasma cells(ratio of IgG4+/IgG+ cells > 40% and >10 IgG4+ plasma cells/HPF).
- •Definite: a + b + c,Probable: a + c,Possible: a + b
- •Excluded from malignant tumors of each organ (e.g. cancer, lymphoma) and similar diseases (e.g. Sjögren's syndrome, primary sclerosing cholangitis, Castleman's disease, secondary retroperitoneal fibrosis, Wegener's granulomatosis, sarcoidosis, Churg-Strauss syndrome) by additional histopathological examination.
- •Even when patients cannot be diagnosed using the Comprehensive diagnostic criteria, they may be diagnosed using organ-specific diagnostic criteria for IgG4-RD, such as Diagnostic criteria for IgG4-Mikulicz's disease.
排除标准
- •Subjects having received steroids or immunosuppressants in recent 3 months will be excluded.
- •Subjects who were hypersensitive to leflunomide will be excluded.
- •ALT and/or AST is more than two folds of the upper limit of relevant reference value at baseline.
- •WBC is less than 3×10*9/L at baseline.
- •Female patients who are pregnant or breastfeeding.
- •Known significant concurrent medical disease.
研究组 & 干预措施
Prednisone
Prednisone mono-therapy
干预措施: Prednisone (Drug)
Prednisone and Leflunomide
Prednisone and Leflunomide combination therapy
干预措施: Prednisone (Drug)
Prednisone and Leflunomide
Prednisone and Leflunomide combination therapy
干预措施: Leflunomide (Drug)
结局指标
主要结局
Relapse rate at 12 months.
时间窗: 12 months
Relapse referred to the recurrence of previous clinical manifestations or abnormality of organ-specific imaging findings or serology tests after remission.
次要结局
- Relapse rate at 6 months.(6 months)
- Serum IgG4 concentrations (mg/dL) measured by immunonephelometry at 1, 3, 6 and 12 months.(Up to 12 months)
- Number of circulating plasmablasts (cell number/mL) assessed by flow cytometry by gating peripheral blood at 1, 3, 6 and 12 months.(Up to 12 months)
- Complete response assessed by IgG4-RD Responder Index (IgG4-RD RI) at 1, 3, 6 and 12 months.(Up to 12 months)
- Partial response assessed by IgG4-RD RI at 1, 3, 6 and 12 months.(Up to 12 months)
- Adverse effect events(Up to 12 months)
研究者
Jian Zhu
Deputy Director of Rheumatology
Chinese PLA General Hospital