CTIS2024-514156-33-00进行中（未招募）1 期
MAINEPSAN : A Prospective Comparative Randomized Double-blind Placebo-controlled In-Parallel Groups Multicenter, Study to Evaluate the remission MAINtenance using Extended administration of Prednisone in Systemic anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 146
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Patients who has been informed about the study and has given his/her written informed consent prior to participation in the study, Patients with newly-diagnosed or relapsing MPA or GPA according to the ACR 1990 criteria and/or revised Chapel Hill Consensus Conference definition, independently of ANCA status, Patients aged of 18 years or older,, Patients in remission (BVAS=0) for MPA or GPA achieved with rituximab, cyclophosphamide, or methotrexate,, Patients who will all have already received glucocorticoids for 12 and 36 months ± 8 weeks after diagnosis or last flare before Day 1 for patients treated according the MAINRITSAN and MAINRITSAN3 protocols, respectively., At Inclusion visit day, patient must be between 5 and 10 mg/day prednisone and at randomization visit day (D1), patient must be at 5 mg/day prednisone, Patients having received 500 mg low-dose rituximab maintenance infusion at remission achievement, according to the MAINRITSAN and MAINRITSAN3 trials
排除标准
- •Patients with GPA or MPA if glucocorticoids treatment has been increased > 10 mg/day for vasculitis flare or stopped during maintenance therapy, Patients suspected not to be observant to the proposed treatments, Patients who have neutrophils cell count =1.500 /mm3,, Patients who have platelet count =100,000/mm3,, Patients with severe hypogammaglobulinemia (invasive bacterial or fungal infection with IgG < 5 g/L or IgG < 3 g/L in patients without infection), Patients who have ALT or AST or GGT or PAL level greater than 3 times the upper limit of normal or total bilirubin level greater than 2 times the upper limit of normal that cannot be attributed to underlying MPA-GPA disease,, Patients unable to give written informed consent prior to study participation., Patients under judicial protection,, Patient not affiliated to a social security scheme or other social protection scheme,, Patients who did not get vaccinated of covid-19 according to national recommendations., Patients with EGPA, or other vasculitides, defined by the ACR criteria and/or the Chapel Hill Consensus Conference, Patients with vasculitis with active disease defined as a BVAS >0,, Patients with acute infections including Sars COVID-19 or chronic active infections (including HIV, HBV or HCV), Patients with active cancer or recent cancer (<5 years) or myelodysplasia, except basocellular carcinoma and low activity prostatic cancer controlled by hormonal treatment, Pregnant women and lactation. Patients with childbearing potential should have reliable contraception for the total duration of the study, Patients with contraindication to use rituximab, 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 excepted for the PNEUMOVAS trial.
研究者
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