Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides

University of Parma

Status and phase: Unknown; Phase 2

Conditions: Polyarteritis Nodosa; Wegener's Granulomatosis; Microscopic Polyangiitis; Churg-Strauss Syndrome

Treatments: Drug: Cyclophosphamide; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT00751517

PCM 01

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

A

Active Comparator group

Description:

Cyclophosphamide

Treatment:

Drug: Cyclophosphamide

B

Experimental group

Description:

Methotrexate

Treatment:

Drug: Methotrexate