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Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome)

NCT00647166 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-09-12

No results posted yet for this study

Summary

To determine whether a combination of corticosteroids and azathioprine can achieve a higher remission rate and a lower subsequent relapse rate in patients with newly-diagnosed microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) with no poor prognosis factor (FFS=0), and without significantly increasing the rate of adverse events, as compared to corticosteroids alone. The study hypothesis is a reduction of the absolute risk of treatment failure or relapse within the first 24 months following initiation of therapy of least 25%.

Conditions

  • MPA
  • PAN or EGPA With FFS=0
  • At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids

Interventions

DRUG

corticosteroid and azathioprine

* Corticosteroid 1 mg/kg/day with a conventional decrease dose * Azathioprine : 2 mg/kg/day during one year in 2 to 3 times a day by oral route

DRUG

corticosteroid and placebo

* Corticosteroid 1 mg/kg/day with a conventional decrease dose * Placebo : 2 mg/kg/day during one year in 2 to 3 times a day by oral route

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Loic Guillevin, MD, PhD · French Vasculitis Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2015-03-31
Completion
2015-04-30

Countries

  • France

Study Locations

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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 NCT00647166 on ClinicalTrials.gov