Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders : the MONIRITUX Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Patients with (Immune Thrombocytopenia) ITP
研究概览
简要总结
The MONIRITUX study aimed to evaluate whether monitoring (i) circulating B-cell reconstitution or (ii) serum rituximab levels could help identify relapse of autoimmune diseases in patients treated with rituximab. Retrospective data suggest that B-cell reconstitution or the appearance of anti-drug antibodies are associated with rituximab's failure to prevent relapses (i.e. rheumatoid arthritis, systemic lupus erythematosus, autoimmune cytopenia...). According to the routine care provided by our institution, patients undergoing rituximab therapy are monitored every three months during the first year after treatment induction and every six months thereafter. At each clinical visit, a blood test is performed to quantify total gammaglobulins, IgG and CD19+ cells (along with other tests depending on the disease). This study will use the remaining blood in the tubes from routine care to quantify CD27+ and CD38+ B cells, as well as serum rituximab and anti-rituximab antibodies, during the first year of follow-up. The primary outcome will be to identify risk factors for clinical relapse according to circulating B-cell or rituximab status.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who undergo rituximab treatment according to routine care and having one of the following disorder:
- •primary immune thrombocytopenia
- •primary autoimmune hemolytic anemia
- •systmic lupus erythematous
- •systemic sclerosis
- •rheumatoid arthritis
- •inflammatory myopathy
- •ANCA associated vasculitis
- •Cryoglobulinemic vasculitis
排除标准
- •Patients undergoing multiple immunosuppressive drugs because of refractory disease or concomitant hemopathy or malignancy
结局指标
主要结局
Patients with (Immune Thrombocytopenia) ITP
时间窗: At each consultation during 5 years
Hematologic relapse described as a drop in platelet count below 20 G/L following a remission phase of at least 3 months with platelet count greater than 50 G/L.
Patients with AIHA Autoimmune Hemolytic Anemia.
时间窗: At each consultation during 5 years
Hematologic relapse described as a drop in hemoglobin level below 10 g/dL (with a lost of at least 2 g/dL from baseline) in association with hemolysis after e remission of at least 3 months
Patients with inflammatory myopathy
时间窗: At each consultation during 5 years
Clinical relase defined as a confirmed muscular (myalgia associated with at least one from the following : increase CK levels, new or worsening electromyography, new or worsening muscle inflammation on MRI), joint or pulmonary new symptoms related to myositis
Patients with systemic lupus erythematous :
时间窗: At each consultation during 5 years
Clinical relapse defined as an increase by 4 points in the SLEDAI (systemic lupus erythematous disease activity index) score
Patients with systemic vasculitis
时间窗: At each consultation during 5 years
Clinical relapse defined as an increase by 1 points in the Birmingham vasculitis (BVAS) score
次要结局
未报告次要终点