Cyclophosphamide and Prednisone Followed by Methotrexate To Treat Vasculitides

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

Keywords

ClinConnect Summary

The purpose of this study is to assess the efficacy and safety of a staged treatment regimen in Wegener's granulomatosis and related vasculitides in which patients will receive glucocorticoid plus cyclophosphamide at disease onset; cyclophosphamide will be switched to methotrexate upon disease remission. At the current time, cyclophosphamide plus glucocorticoids are the standard of care for the treatment of these disorders. Although this regimen has brought about a marked improvement in survival rate, it has been associated with significant toxicity. Methotrexate plus glucocorticoids have r...

Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA:
• • Documentation of WG based on clinical characteristics and histopathological evidence of vasculitis. Patients with a positive C- or P-ANCA and glomerulonephritis as evidence by the presence of red blood cell casts and proteinuria or renal biopsy showing necrotizing glomerulonephritis in the absence of positive immunofluorescence for immunoglobulin and complement will also be eligible.
• • Age 10-80 years.
• • Evidence of active disease as defined by a Vasculitis Disease Activity Index of greater than or equal to 3 or if begun on CTX and glucocorticoid at an outside institution, a history of a Vasculitis Disease Activity Index greater than or equal to 3 at the time of therapy initiation.
• EXCLUSION CRITERIA:
• • Evidence of active systemic infection which, in the judgement of the investigator, is of greater danger to the patient than the underlying vasculitis. In those instances in which infection cannot be ruled out by gram stain and culture of secretions or collections of fluid in involved organs, it may be necessary to obtain a biopsy of the affected tissue for microbiological and histopathological studies.
• • Patients who are pregnant or who are nursing infants will not be eligible. Fertile women must have a negative pregnancy test within one week prior to study entry and must be using an effective means of birth control.
• • Processes associated with an increased risk of MTX toxicity: acute or chronic liver disease, past history of alcohol abuse (greater than 14 oz. of 100 proof liquor or equivalent per week), ongoing alcohol use of any volume that cannot be discontinued upon entry into the study.
• • Serological evidence of infection with human immunodeficiency virus, hepatitis C, or a positive hepatitis B surface antigen. A serological determination will be performed within two weeks of beginning study participation.
• • Inability to comply with study guidelines.