PDF(Pubmed)
Abstract：
BACKGROUND: Several studies have demonstrated that mycophenolate mofetil (MMF) may be an excellent alternative to cyclophosphamide (CYC) or rituximab for the induction of remission in non-life-threatening anti-neutrophil cytoplasmic antibodies associated vasculitis because of its strong immunosuppressive potency and low toxicity profile. Enteric-coated mycophenolate sodium (EC-MPS) was introduced to reduce gastrointestinal adverse reactions of MMF. This study will evaluate the efficacy and safety of EC-MPS combined with glucocorticoid in patients with active and non-life-threatening microscopic polyangiitis (MPA).
METHODS: This study is a multicentre, open-label, randomised controlled, non-inferiority trial. A total of 110 patients with active and non-life-threatening MPA from 11 hospitals in Shanxi Province of China will be recruited and randomised in a 1:1 ratio to receive either EC-MPS or CYC. All patients will receive the same glucocorticoid plan. We will compare oral EC-MPS (720-1440 mg/day) with intravenous pulsed CYC (7.5-15 mg/kg) administered for 3-6 months. All patients will be switched from their assigned treatment (EC-MPS or CYC) to oral azathioprine (2 mg/kg/day) after remission has been achieved, between 3 and 6 months. Azathioprine will be continued until the study ends at 18 months. The primary end point of efficacy is the remission rate at 6 months. Follow-up will continue for 18 months in order to detect an influence of induction regimen on subsequent relapse rates.
BACKGROUND: This study has received approval from the Ethics Committee of the Second Hospital of Shanxi Medical University (2022YX-026). All participants are required to provide written informed consent and no study-related procedures will be performed until consent is obtained. The results of this trial will be published in peer-reviewed journals and presented at conferences.
BACKGROUND: ChiCTR2200063823.
METHODS: This study is a multicentre, open-label, randomised controlled, non-inferiority trial. A total of 110 patients with active and non-life-threatening MPA from 11 hospitals in Shanxi Province of China will be recruited and randomised in a 1:1 ratio to receive either EC-MPS or CYC. All patients will receive the same glucocorticoid plan. We will compare oral EC-MPS (720-1440 mg/day) with intravenous pulsed CYC (7.5-15 mg/kg) administered for 3-6 months. All patients will be switched from their assigned treatment (EC-MPS or CYC) to oral azathioprine (2 mg/kg/day) after remission has been achieved, between 3 and 6 months. Azathioprine will be continued until the study ends at 18 months. The primary end point of efficacy is the remission rate at 6 months. Follow-up will continue for 18 months in order to detect an influence of induction regimen on subsequent relapse rates.
BACKGROUND: This study has received approval from the Ethics Committee of the Second Hospital of Shanxi Medical University (2022YX-026). All participants are required to provide written informed consent and no study-related procedures will be performed until consent is obtained. The results of this trial will be published in peer-reviewed journals and presented at conferences.
BACKGROUND: ChiCTR2200063823.
摘要：
背景：多项研究表明，霉酚酸酯（MMF）可能是环磷酰胺（CYC）或利妥昔单抗的理想替代品，用于诱导非危及生命的抗中性粒细胞胞浆抗体相关血管炎缓解，因为它具有强大的免疫抑制效力和低毒性。引入肠溶霉酚酸钠（EC-MPS）以减少MMF的胃肠道不良反应。这项研究将评估EC-MPS联合糖皮质激素在活动性和非危及生命的显微镜下多血管炎（MPA）患者中的疗效和安全性。
方法：这项研究是一个多中心，开放标签，随机对照，非自卑审判。来自中国山西省11家医院的110名活动性和非危及生命的MPA患者将被招募并以1：1的比例随机分配，以接受EC-MPS或CYC。所有患者将接受相同的糖皮质激素计划。我们将比较口服EC-MPS（720-1440mg/天）与静脉内脉冲CYC（7.5-15mg/kg）给药3-6个月。缓解后，所有患者将从指定的治疗（EC-MPS或CYC）转换为口服硫唑嘌呤（2mg/kg/天）。在3到6个月之间。硫唑嘌呤将继续进行，直到研究在18个月结束。疗效的主要终点是6个月时的缓解率。随访将持续18个月，以检测诱导方案对后续复发率的影响。
背景：本研究已获得山西医科大学第二医院伦理委员会的批准（2022YX-026）。所有参与者都需要提供书面知情同意书，并且在获得同意之前不进行与研究相关的程序。这项试验的结果将发表在同行评审的期刊上，并在会议上发表。
背景：ChiCTR2200063823。
方法：这项研究是一个多中心，开放标签，随机对照，非自卑审判。来自中国山西省11家医院的110名活动性和非危及生命的MPA患者将被招募并以1：1的比例随机分配，以接受EC-MPS或CYC。所有患者将接受相同的糖皮质激素计划。我们将比较口服EC-MPS（720-1440mg/天）与静脉内脉冲CYC（7.5-15mg/kg）给药3-6个月。缓解后，所有患者将从指定的治疗（EC-MPS或CYC）转换为口服硫唑嘌呤（2mg/kg/天）。在3到6个月之间。硫唑嘌呤将继续进行，直到研究在18个月结束。疗效的主要终点是6个月时的缓解率。随访将持续18个月，以检测诱导方案对后续复发率的影响。
背景：本研究已获得山西医科大学第二医院伦理委员会的批准（2022YX-026）。所有参与者都需要提供书面知情同意书，并且在获得同意之前不进行与研究相关的程序。这项试验的结果将发表在同行评审的期刊上，并在会议上发表。
背景：ChiCTR2200063823。
