Evaluation and Prediction of Relapse Risk After Glucocorticoid and Immunosuppressant Withdrawal in Patients With Stable IgG4 Related Disease: An Open-labeled Multi-centric Randomized Controlled Study From China
试验速览
- 阶段
- 不适用
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- The difference of recurrent rate of IgG4-RD among three groups.
研究概览
简要总结
Evaluation and prediction of relapse risk after glucocorticoid or immunosuppressant withdrawal in patients with stable IgG4 related disease: a prospective cohort study from china.
详细描述
IgG4-related disease (IgG4-RD) is a chronic autoimmune disease with a relapsing-remitting course. For patients in remission, glucocorticoid (GC) and immunosuppressant are used to be maintained for a long time in fear of disease flare. Long-term GC and immunosuppressant could bring a lot of side-effects and economic burden. Whether and when patients with stable disease should withdraw GC or immunosuppressant? How about the relapse risk respectively? What are the risk factors for disease flare? All the above remain unclear. The aim of this study is to explore the relapse risk after GC or immunosuppressant withdrawal in IgG4-RD patients with stable disease and to establish a predictive model for risk stratification. Meanwhile the investigators aim to testify the effects of immunosuppressant in preventing IgG4-RD relapse. This study is a prospective cohort clinical trial.
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
- •All patients must meet the following diagnostic criteria of IgG4RD (2011): 1)Swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions; 2)Elevated serum IgG4 (>1.35 g/L); 3)Histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD. exclusion of other diseases.
- •Disease stabilized more than one year (Responder Index < 2 points)
- •Dose of Glucocorticoid(GC): prednisone (or equivalent) ≤ 7.5mg/d for more than 6 months
- •Immunosuppressant: one of the following drugs, the same dose maintain at least 3 months (Mycophenolate mate <= 1g/d or Leflunomide <=20mg/d or Methotrexate <=12.5mg/w or Azathioprine <=100mg/d).
排除标准
- •Patient was diagnosed other connective tissue diseases
- •Patient with tumor
- •Women during pregnancy or planning pregnancy
- •Patient with active infections, including HIV, HCV, HBV, TB, etc.
- •Patient with severe irreversible organ damage
- •Active IgG4-RD, responder index >= 2 points
- •Stable condition less than one year.
- •Patient with two or more immunosuppressive agents.
- •Biological agents (such as CD20 monoclonal antibody and TNF-a inhibitor) have been used for half a year before admission.
- •Patient with IgG4-RD recurrence during hormone reduction in the past.
研究组 & 干预措施
Drug free
Arm A: Drug free Glucocorticoid（GC）is tapered and stopped in 8 weeks(GCs at a dose of ≤ 2.5 mg of prednisone or equivalent for treatment of adrenal insufficiency) .
Immunosuppressant is also tapered and discontinues in 8 weeks.
干预措施: Drug free, IS monotherapy and GC combined with IS (Drug)
IS monotherapy
Arm B: Immunosuppressant only Glucocorticoid（GC）is tapered and stopped in 8 weeks. The same type and dosage of immunosuppressive agent before admission, including Mycophenolate mate(<= 1g/d) or Leflunomide (<=20mg/d) or Methotrexate (<=15mg/w) or Azathioprine (<=100mg/d)
干预措施: Drug free, IS monotherapy and GC combined with IS (Drug)
GC combined with IS
Arm C: GC+Immunosuppressant Both Glucocorticoid(GC) (no more than 7.5mg/d) and immunosuppressant are kept as maintaining dose.
干预措施: Drug free, IS monotherapy and GC combined with IS (Drug)
结局指标
主要结局
The difference of recurrent rate of IgG4-RD among three groups.
时间窗: One and half year
Clinical recurrence definition: any item of IgG4-RD Responder Index \>=2，new organ involvement; with or without elevated serum IgG4 levels. Serum recurrence definition: Serum IgG4 level was higher than baseline level, IgG4-RD Responder Index was higher than or equal to 1 point, without clinical symptom or imaging deterioration.
次要结局
- The changes of serum hsCRP level(One and half year)
- The changes of ESR(One and half year)
- The changes of serum IgG4 levels(One and half year)
- The changes of serum IgG level(One and half year)
- The percentages of adverse events(One and half year)
- The changes of IgG4-RD Responder Index(One and half year)
研究者
Wen Zhang
Professor
Peking Union Medical College Hospital