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

NCT00307645 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2006-04-10

No results posted yet for this study

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

Conditions

  • ANCA Associated Systemic Vasculitis Including Wegener's
  • Granulomatosis and Microscopic Polyangiitis and
  • Renal Limited Vasculitis

Interventions

DRUG

Cyclophosphamide

DRUG

Mycophenolate mofetil

DRUG

Azathioprine

DRUG

Prednisone (and methylprednisolone)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Loïc GUILLEVIN, MD,PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Completion
2009-08-31

Countries

  • France
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00307645 on ClinicalTrials.gov