drugset / Trial / NCT00307645

IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis

NCT00307645

Phase 3 Terminated 160 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of IMPROVE is to define the optimal maintenance therapy for ANCA-associated vasculitides (AASV) by comparing the AZA (standard regimen) with MMF in terms of efficacy, i.e. in preventing relapses. HYPOTHESIS : MMF might be more effective than azathioprine as maintenance drug in AASV patients, reducing by 50% relapse rate, with a same frequency of adverse effects

Timeline

Start
2003-05
Primary completion
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Azathioprine Small molecule 2 mg/kg
Subject Mycophenolate Mofetil Small molecule 2000 mg
Background Cyclophosphamide Other / unclassified
Background Methylprednisolone Other / unclassified
Background Prednisone Other / unclassified