Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis : a Predictive Factor of Clinical Outcome? (MONITUX)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- serum rituximab levels
研究概览
简要总结
The aim of the investigators' study is to evaluate whether monitoring serum rituximab levels could be an interesting tool in the follow-up of ANCA-associated vasculitis patients.
All consecutive patients, hospitalized for a new diagnosis of ANCA-associated vasculitis or the relapse of a known ANCA-associated vasculitis, in which the decision to start an induction regimen with rituximab has been taken, will be included.
Serum rituximab levels (along with serum anti-rituximab antibodies levels) will be determined (at M+1 and M+3) and the correlation with clinical outcome at M+6 will be analyzed.
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
- •Age > 18 years
- •Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA
- •Decision taken to start an induction regimen with rituximab
- •Informed and having signed the study consent form
- •If of child-bearing potential, female patients will have use an effective method of contraception during RTX (rituximab) treatment and in the 12 months following RTX treatment stop
- •no-breast-feeding during RTX treatment and in the 12 months following RTX treatment stop
排除标准
- •Other primary or secondary systemic vasculitis
- •Incapacity or refusal to sign the informed consent form
- •Incapacity or refusal to adhere to treatment or perform the follow-up examinations required by the study
- •Allergy, documented hypersensitivity or contraindication to the medications used in the present study (corticosteroids, rituximab)
- •severe active infection
- •Patient with severe heart failure (stage NYHA IV) or any other unstable heart disease Pregnancy, except for cases where the expected benefit oj treatment seems to surpass the potential risks
- •Patients with active hepatitis B
- •Any live vaccine within four weeks prior to the first infusion of RTX
结局指标
主要结局
serum rituximab levels
时间窗: 1 month after stop of rituximab induction regimen
rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0, 6 months after stop of induction regimen
次要结局
- serum rituximab levels(6 months after stop of rituximab induction regimen)
- serum anti-rituximab antibodies(6 months after stop of rituximab induction regimen)
- Serum B lymphocytes (CD19+ cells) levels(6 months after stop of rituximab induction regimen)
- patient number with adverse event(from start of induction rituximab regimen until six monthes after stop of induction regimen)