Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides
This trial is active, not recruiting.
|Conditions||wegener's granulomatosis, churg-strauss syndrome, microscopic polyangiitis, polyarteritis nodosa|
|Sponsor||University of Parma|
|Trial identifier||NCT00751517, PCM 01|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Time from remission to relapse
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - Diagnosis of clinically active SNV - Life-expectancy > 1 year - Written informed consent Exclusion Criteria: - Creatinine clearance < 10 ml/min/1.73 mq - Aminotransferase levels more than twice the upper limit of the normal range - HBsAg positivity - anti-HCV Ig and HCV-RNA positivity - HIV positivity - Active malignancies - Coexistence of connective tissue disease - Prednisolone, cyclophosphamide or methotrexate hypersensitivity - Pregnancy
|Official title||Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.|
|Principal investigator||Carlo Buzio, MD|
Call for more information