Clinical Trial: Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.
Brief Summary: The Systemic Necrotizing Vasculitides (SNV) encompass a group of rare diseases which include Wegener's Granulomatosis (WG), Churg-Strauss Syndrome (CSS), Microscopic polyangiitis (MPA)and Polyarteritis nodosa (PAN). Common histological findings are inflammation with fibrinoid necrosis of the small vessels and sporadic or absent immune-deposits. The gold standard therapy for SNV is currently represented by the association of Cyclophosphamide and Prednisone. The limits of this approach are the high frequency of recurrent disease and an increased incidence of malignancy and infections. The aim of the present study is to compare the efficacy of Methotrexate vs Cyclophosphamide for Remission Maintenance in SNV.
Detailed Summary:
Sponsor: University of Parma
Current Primary Outcome: Time from remission to relapse
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Recurrence rate
- Therapy-related toxicity
- Hospitalization rate
- Mortality
Original Secondary Outcome: Same as current
Information By: University of Parma
Dates:
Date Received: September 11, 2008
Date Started:
Date Completion:
Last Updated: September 11, 2008
Last Verified: September 2008
