Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides

Microscopic Polyangiitis Clinical Trial

Official title:

Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00751517
• Other study ID #: PCM 01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 11, 2008
• Last updated: September 11, 2008

Study information

• Verified date: September 2008
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Churg-Strauss Syndrome
• Microscopic Polyangiitis
• Polyarteritis Nodosa
• Systemic Vasculitis
• Vasculitis
• Wegener Granulomatosis
• Wegener's Granulomatosis

Intervention

Drug:
• Methotrexate

• Cyclophosphamide

Locations

Country	Name	City	State
Italy	Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital	Parma	Italy/Parma

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Falk RJ, Jennette JC. ANCA small-vessel vasculitis. J Am Soc Nephrol. 1997 Feb;8(2):314-22. Review. — View Citation

Gordon M, Luqmani RA, Adu D, Greaves I, Richards N, Michael J, Emery P, Howie AJ, Bacon PA. Relapses in patients with a systemic vasculitis. Q J Med. 1993 Dec;86(12):779-89. — View Citation

Hoffman GS, Kerr GS, Leavitt RY, Hallahan CW, Lebovics RS, Travis WD, Rottem M, Fauci AS. Wegener granulomatosis: an analysis of 158 patients. Ann Intern Med. 1992 Mar 15;116(6):488-98. — View Citation

Hoffman GS. Wegener's granulomatosis. Curr Opin Rheumatol. 1993 Jan;5(1):11-7. Review. — View Citation

Talar-Williams C, Hijazi YM, Walther MM, Linehan WM, Hallahan CW, Lubensky I, Kerr GS, Hoffman GS, Fauci AS, Sneller MC. Cyclophosphamide-induced cystitis and bladder cancer in patients with Wegener granulomatosis. Ann Intern Med. 1996 Mar 1;124(5):477-84. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from remission to relapse			No
Secondary	Recurrence rate
Secondary	Therapy-related toxicity
Secondary	Hospitalization rate
Secondary	Mortality