Overview

This trial is active, not recruiting.

Conditions wegener's granulomatosis, churg-strauss syndrome, microscopic polyangiitis, polyarteritis nodosa
Treatments methotrexate, cyclophosphamide
Phase phase 2
Sponsor University of Parma
Trial identifier NCT00751517, PCM 01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Cyclophosphamide
cyclophosphamide
(Experimental)
Methotrexate
methotrexate

Primary Outcomes

Measure
Time from remission to relapse
time frame:

Secondary Outcomes

Measure
Recurrence rate
time frame:
Therapy-related toxicity
time frame:
Hospitalization rate
time frame:
Mortality
time frame:

Eligibility Criteria

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

Additional Information

Official title Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.
Principal investigator Carlo Buzio, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2008.
Information provided to ClinicalTrials.gov by University of Parma.