Status:
UNKNOWN
WEGENT - Comparison of Methotrexate or Azathioprine as Maintenance Therapy for ANCA-Associated Vasculitides
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Systemic Wegener's Granulomatosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Remission of ANCA-associated vasculitis can be obtained in approximately 80% of the patients with a combination of corticosteroids and cyclophosphamide. However, relapses are frequent. This point warr...
Eligibility Criteria
Inclusion
- Patients aged over 18 years-old with newly diagnosed systemic Wegener's granulomatosis,
- microscopic polyangitis with at least one factor of poor prognosis according to the five factors score (proteinuria \> 1 g/day, renal insufficiency defined as a serum creatininemia \> 140 µmol/L, specific cardiomyopathy, gastrointestinal tract and/or CNS involvement).
Exclusion
- MPA patients with no poor prognosis factor;
- localized WG;
- relapse of previously known WG or MPA;
- treatment with corticosteroids for more than 1 month prior to diagnosis and start of immunosuppressant;
- co-existence of another multi-system autoimmune disease;
- malignancy (unless considered in complete remission and with no therapy for at least 3 years);
- contra-indication to corticosteroids or study immunosuppressants; pregnancy or no use of contraception in non-menopaused women;
- infection with human immunodeficiency virus; mental or physical disturbances not permitting to give consent.
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00349674
Start Date
January 1 1999
Last Update
October 10 2007
Active Locations (1)
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1
Christian PAGNOUX
Paris, France, 75