Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides

The recruitment status of this study is unknown because the information has not been verified recently.

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

Sponsor:

Information provided by:

University of Parma

ClinicalTrials.gov Identifier:

NCT00751517

First received: September 11, 2008

Last updated: NA

Last verified: September 2008

History: No changes posted

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 NLM:

MedlinePlus related topics: Vasculitis Wegener's Granulomatosis

Drug Information available for: Cyclophosphamide Methotrexate Methotrexate sodium

U.S. FDA Resources

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
Active Comparator: A Cyclophosphamide	Drug: Cyclophosphamide
Experimental: B 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
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:	Carlo Buzio, University of Parma
ClinicalTrials.gov Identifier:	NCT00751517 History of Changes
Other Study ID Numbers:	PCM 01
Study First Received:	September 11, 2008
Last Updated:	September 11, 2008
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Parma:

Vasculitis
Cyclophosphamide
Methotrexate
Systemic Necrotizing Vasculitides

Additional relevant MeSH terms:

Churg-Strauss Syndrome
Polyarteritis Nodosa
Vasculitis
Wegener Granulomatosis
Systemic Vasculitis
Microscopic Polyangiitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vascular Diseases
Cardiovascular Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Autoimmune Diseases
Immune System Diseases
Arteritis

Skin Diseases, Vascular
Skin Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Cyclophosphamide
Methotrexate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on May 19, 2013

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