EUCTR2018-001215-69-FRActive, not recruitingPhase 1
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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 146
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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,
Investigators
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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.Patients in remission for granulomatosis with polyangiitis (GPA,Wegener's) or microscopic polyangiitis (MPA) achieved with rituximab orcyclophosphamide or methotrexateMedDRA version: 20.1Level: PTClassification code: 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitis Class: 100000004870CTIS2024-514156-33-00Hospices Civils De Lyon146
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