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

Phase 1

Conditions: Patients with newly diagnosed or relapsing granulomatosis with polyangiitis (GPA, Wegener’s) or microscopic polyangiitis (MPA) , 12 months after initiation of treatment for vasculitis onset or flare, while being treated with rituximab (500 mg fixed low-dose) maintenance therapy every 6 months. Eligible patients are those in remission and receiving a prednisone dose of 5-10 mg/day, 12 months after vasculitis onset or flare, at the second rituximab maintenance infusion
MedDRA version: 20.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem Organ Class: 10021428 - Immune system disorders
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2018-001215-69-FR

Lead Sponsor: Hospices Civils de Lyon

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 146

Inclusion Criteria

-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

Exclusion Criteria

-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,