EUCTR2016-000275-25-FR进行中（未招募）1 期
Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVAS
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients with a diagnosis of EGPA independently of ANCA status,
- •-Patient aged of 18 years or older,
- •-Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an active disease defined as a Birmingham Vasculitis Activity Score (BVAS) > ou=3,
- •-Patients within the first 21 days following initiation/increase of corticosteroids at a dose -Patient able to give written informed consent prior to participation in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 108
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients with GPA, MPA, or other vasculitides, defined by the ACR criteria and/or the Chapel Hill Consensus Conference,
- •-Patients with vasculitis in remission of the disease defined as a BVAS <3,
- •-Patients with severe cardiac failure defined as class IV in New York Heart Assocation
- •-Patients with acute infections or chronic active infections (including HIV, HBV or HCV),
- •Patients with active cancer or recent cancer (<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment,
- •Pregnant women and lactation. Patients with childbearing potential should have reliable contraception for the all duration of the study,
- •-Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
- •Patients with EGPA who have already been treated with rituximab within the previous 12 months,
- •-Patients with hypersensitivity to a monoclonal antibody or biologic agent,
- •-Patients with contraindication to use rituximab or cyclophosphamide,(only patients DFS< ou=1)
- •-Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
- •-Patients included in other investigational therapeutic study within the previous 3 months,
- •-Patients suspected not to be observant to the proposed treatments,
- •-Patients who have white blood cell count < ou=4,000/mm3,
- •-Patients who have platelet count < ou =100,000/mm3,
- •-Patients who have ALT or AST level greater that 3 times the upper limit of normal that cannot be attributed to underlying EGPA disease,
- •-Patients unable to give written informed consent prior to participation in the study.
研究者
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