WEGENT - Comparison of Methotrexate or Azathioprine as Maintenance Therapy for ANCA-Associated Vasculitides
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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 warrants the prescription of a maintenance treatment with a less toxic
immunosuppressant for several months to years. The optimal drug in this indication is not
determine. We decided therefore to compare the 2 most used drugs in this indication.
Induction therapy consists in the combination of corticosteroids and intravenous
cyclophosphamide pulses. Corticotherapy consisted first in one daily methylprednisolone
pulse, for 1 to 3 days, followed by oral prednisolone at the dose of 1 mg/kg/d for 3 weeks,
then progressively tapered and stopped at the 18th month from the diagnosis. Cyclophosphamide
is administered every 2 weeks for the first 3 bolus (0.6 g/m2 - D1, 15 and 30), then every 3
weeks (0.7 g/m2). Once remission is achieved, patients receive 3 additional bolus (0.7 g/m2).
At that time, patients are randomized for a maintenance treatment with azathioprine (2
mg/kg/d, orally) or oral methotrexate (starting at the dose of 0.3 mg/kg/wk, then
progressively increased every weeks by 2.5mg, if necessary, to a maximum and optimal dose of
25 mg/wk) for 12 months.