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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of a New Treatment Strategy for Patients With Microscopic Polyangiitis, Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (

  • initial remission rate (independently of subsequent relapse) [ Time Frame: 24 months ]
  • number of patients who have a minor or major relapse [ Time Frame: 24 months ]
  • number of serious treatment-related adverse effects [ Time Frame: 24 months ]
  • number of patients with at least one treatment-related adverse effect [ Time Frame: 24 months ]
  • severity of treatment-related effects according to the WHO toxicity grading system (grades 1 to 4; grades 3 and 4 for the severity) [ Time Frame: 24 months ]
  • number of deaths and causes [ Time Frame: 24 months ]
  • number of patients who could not be weaned of corticosteroids and dose required [ Time Frame: 24 months ]
  • area under the curve for corticosteroids [ Time Frame: 24 months ]
  • different scales, such as BVAS (activity of the disease), VDI (damage), HAQ, SF36, ADL and the evaluation of the need for health care facilities. [ Time Frame: 24 months ]
  • number of flares with or without asthma and/or eosinophilia (only for EGPA analysis) [ Time Frame: 24 months ]


    • Original Secondary Outcome:

    • initial remission rate (independently of subsequent relapse) [ Time Frame: 24 months ]
    • rates of adverse events and their severity according to the WHO toxicity grading system [ Time Frame: 24 months ]
    • number of deaths [ Time Frame: 24 months ]
    • number of patients who could not be weaned of corticosteroids [ Time Frame: 24 months ]
    • area under the curve for corticosteroids [ Time Frame: 24 months ]
    • different scales, such as BVAS (activity of the disease), VDI (damage), HAQ, SF36, ADL and the evaluation of the need for health care facilities. [ Time Frame: 24 months ]


    Information By: Assistance Publique - Hôpitaux de Paris

    Dates:
    Date Received: March 26, 2008
    Date Started: May 2008
    Date Completion:
    Last Updated: October 6, 2015
    Last Verified: October 2015