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Clinical Trials/EUCTR2018-001215-69-FR
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

Hospices Civils de Lyon0 sites146 target enrollmentStarted: July 2, 2018Last updated:

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
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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