Trial Information
Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time from remission to relapse
Safety Issue:
No
Principal Investigator
Carlo Buzio, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Parma
Authority:
Italy: Ethics Committee
Study ID:
PCM 01
NCT ID:
NCT00751517
Start Date:
Completion Date:
Related Keywords:
- Wegener's Granulomatosis
- Churg-Strauss Syndrome
- Microscopic Polyangiitis
- Polyarteritis Nodosa
- Vasculitis
- Cyclophosphamide
- Methotrexate
- Systemic Necrotizing Vasculitides
- Churg-Strauss Syndrome
- Polyarteritis Nodosa
- Vasculitis
- Wegener Granulomatosis
- Systemic Vasculitis
- Microscopic Polyangiitis