Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides - Full Text View

Purpose

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.

Condition	Intervention	Phase
Wegener's Granulomatosis Churg-Strauss Syndrome Microscopic Polyangiitis Polyarteritis Nodosa	Drug: Methotrexate Drug: Cyclophosphamide	Phase II

MedlinePlus related topics:

Vasculitis Wegener's Granulomatosis

ChemIDplus related topics:

Cyclophosphamide Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by University of Parma:

Primary Outcome Measures:

Time from remission to relapse [ Designated as safety issue: No ]

Secondary Outcome Measures:

Recurrence rate
Therapy-related toxicity
Hospitalization rate
Mortality

Arms	Assigned Interventions
A: Active Comparator Cyclophosphamide	Drug: Cyclophosphamide
B: Experimental Methotrexate	Drug: Methotrexate

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751517

Locations


Italy, Italy/Parma
	Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital
	Parma, Italy/Parma, Italy, 43100

Sponsors and Collaborators

University of Parma

Investigators


Principal Investigator:	Carlo Buzio, MD	University of Parma

More Information

Publications:

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.

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

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.

Falk RJ, Jennette JC. ANCA small-vessel vasculitis. J Am Soc Nephrol. 1997 Feb;8(2):314-22. Review. No abstract available.

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.

Responsible Party:	University of Parma ( Carlo Buzio )
Study ID Numbers:	PCM 01
First Received:	September 11, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00751517
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Parma:

Vasculitis

Cyclophosphamide

Methotrexate

Systemic Necrotizing Vasculitides

Study placed in the following topic categories:

Microscopic polyangiitis

Lung Diseases, Interstitial

Vasculitis

Skin Diseases

Churg-Strauss Syndrome

Churg-Strauss syndrome

Wegener's granulomatosis

Vascular Diseases

Cyclophosphamide

Granuloma

Folic Acid

Lymphatic Diseases

Urologic Diseases

Wegener Granulomatosis

Respiratory Tract Diseases

Polyarteritis

Polyarteritis Nodosa

Lung Diseases

Methotrexate

Kidney Diseases

Arteritis

Lymphoproliferative Disorders

Polyarteritis nodosa

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Reproductive Control Agents

Pathologic Processes

Therapeutic Uses

Syndrome

Abortifacient Agents

Cardiovascular Diseases

Alkylating Agents

Dermatologic Agents

Nucleic Acid Synthesis Inhibitors

Skin Diseases, Vascular

Disease

Enzyme Inhibitors

Abortifacient Agents, Nonsteroidal

Folic Acid Antagonists

Immunosuppressive Agents

Pharmacologic Actions

Myeloablative Agonists

Antineoplastic Agents, Alkylating

Antirheumatic Agents

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	University of Parma
Information provided by:	University of Parma
ClinicalTrials.gov Identifier:	NCT00751517