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