Status:
COMPLETED
Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
MPA
PAN or EGPA With FFS=0
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Patients with new diagnosis of 1) microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) and 2) without any factor of poor prognosis a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00647166
Start Date
May 1 2008
End Date
April 1 2015
Last Update
September 12 2025
Active Locations (1)
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1
Hopital Cochin Pôle de Médecine UF Médecine Interne
Paris, France, 75014