Overview

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

Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
0
Participant gender:
All
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%.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
Azathioprine
Criteria
Inclusion Criteria:

- male or female patients

- aged over 18 years

- new diagnosis of microscopic polyangiitis, polyarteritis nodosa or eosinophilic
granulomatosis with polyangiitis (Churg Strauss syndrome), satisfying ACR 1990 and/or
Chapel Hill Nomenclature criteria (positive biopsy is not mandatory providing those
criteria are fulfilled)

- with no factor of poor prognosis according to the French five factors score (FFS=0)

- at diagnosis or within the first 21 days following initiation of corticosteroids

- signed information and consent form

- patients covered by Health Insurance

- having had a baseline physical examination

Exclusion Criteria:

- patients with microscopic polyangiitis, polyarteritis nodosa or eosinophilic
granulomatosis with polyangiitis (Churg Strauss syndrome) with one or more factor(s)
of poor prognosis according to the French five factors score (FFS ≥ 1)

- patients with polyarteritis nodosa with ANCA, not satisfying the criteria for
microscopic polyangiitis

- patients with clinically overt alveolar hemorrhage or respiratory distress syndrome

- patient treated with corticosteroids for more than 15 days or already receiving
another immunosuppressant

- relapsing vasculitis

- other vasculitis, especially secondary vasculitides

- vasculitis secondary or associated with a viral infection, such as hepatitis B or C
virus, or HIV

- malignancy

- pregnancy and breast feeding,women of child-bearing age not willing or with
contra-indication to receive contraception

- contra-indication to any of the study agents

- need to continue allopurinol for those patients taking allopurinol

- consent deny or inability to receive information and give consent

- participation in another concomitant therapeutic trial

- no affiliation to any of the general French health care system