MAINEPSAN StudyA 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 - MAINEPSA

Hospices Civils de Lyon0 个研究点目标入组 146 人开始时间: 2018年7月2日最近更新: 2024年6月24日

试验速览

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•-Patients who have been informed about the study and have given his/her written 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 or cyclophosphamide or methotrexate,
•-Patients who will all have already received glucocorticoids for 12 months ± 2 weeks after diagnosis or last flare before Day 1.
•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 120
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 26

•-Patients with EGPA (Eosinophilic Granulomatosis with Polyangiitis) , 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 or chronic active infections (including HIV, HBV or HCV),
•-Patients with active or recent cancer (<5 years) or myelodysplasia, except basocellular carcinoma and low activity prostatic cancer controlled by hormonal treatment,
•-Pregnant women and lactation: women of childbearing potential will have to follow an effective method of contraception for the total duration of the study,

发起方