Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides

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ClinicalTrials.gov Identifier: NCT00751517

Recruitment Status : Unknown

Verified September 2008 by University of Parma.
Recruitment status was: Active, not recruiting

First Posted : September 12, 2008

Last Update Posted : September 12, 2008

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

University of Parma

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Wegener's Granulomatosis Churg-Strauss Syndrome Microscopic Polyangiitis Polyarteritis Nodosa	Drug: Methotrexate Drug: Cyclophosphamide	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Granulomatosis with polyangiitis

MedlinePlus related topics: Vasculitis

Drug Information available for: Cyclophosphamide Methotrexate

Genetic and Rare Diseases Information Center resources: Granulomatosis With Polyangiitis Microscopic Polyangiitis Eosinophilic Granulomatosis With Polyangiitis Allergic Angiitis Polyarteritis Nodosa ANCA-associated Vasculitis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: A Cyclophosphamide	Drug: Cyclophosphamide
Experimental: B Methotrexate	Drug: Methotrexate

Outcome Measures

Primary Outcome Measures :

Time from remission to relapse

Secondary Outcome Measures :

Recurrence rate
Therapy-related toxicity
Hospitalization rate
Mortality

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751517

Locations

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

Sponsors and Collaborators

University of Parma

Investigators

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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. doi: 10.7326/0003-4819-116-6-488.

Hoffman GS. Wegener's granulomatosis. Curr Opin Rheumatol. 1993 Jan;5(1):11-7. doi: 10.1097/00002281-199305010-00003.

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. doi: 10.1681/ASN.V82314. 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. doi: 10.7326/0003-4819-124-5-199603010-00003.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Maritati F, Alberici F, Oliva E, Urban ML, Palmisano A, Santarsia F, Andrulli S, Pavone L, Pesci A, Grasselli C, Santi R, Tumiati B, Manenti L, Buzio C, Vaglio A. Methotrexate versus cyclophosphamide for remission maintenance in ANCA-associated vasculitis: A randomised trial. PLoS One. 2017 Oct 10;12(10):e0185880. doi: 10.1371/journal.pone.0185880. eCollection 2017.

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Responsible Party:	Carlo Buzio, University of Parma
ClinicalTrials.gov Identifier:	NCT00751517
Other Study ID Numbers:	PCM 01
First Posted:	September 12, 2008 Key Record Dates
Last Update Posted:	September 12, 2008
Last Verified:	September 2008

Keywords provided by University of Parma:


Vasculitis Cyclophosphamide Methotrexate Systemic Necrotizing Vasculitides

Additional relevant MeSH terms:

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Granulomatosis with Polyangiitis Microscopic Polyangiitis Vasculitis Churg-Strauss Syndrome Polyarteritis Nodosa Vascular Diseases Cardiovascular Diseases Systemic Vasculitis Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Skin Diseases, Vascular Skin Diseases Autoimmune Diseases	Immune System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Granuloma Lymphoproliferative Disorders Lymphatic Diseases Arteritis Cyclophosphamide Methotrexate Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs

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