Churg-Strauss Syndrome, Microscopic Polyangiitis, Polyarteritis Nodosa, Wegener's Granulomatosis
Conditions
Keywords
Vasculitis, Cyclophosphamide, Methotrexate, Systemic Necrotizing Vasculitides
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.
Interventions
DRUGMethotrexate
DRUGCyclophosphamide
Sponsors
University of Parma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from remission to relapse | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate | — |
| Therapy-related toxicity | — |
| Hospitalization rate | — |
| Mortality | — |
Countries
Italy
Outcome results
None listed