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Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides

NCT ID: NCT00751517

Last Updated: 2008-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Vasculitis Cyclophosphamide Methotrexate Systemic Necrotizing Vasculitides

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Cyclophosphamide

Group Type ACTIVE_COMPARATOR

Cyclophosphamide

Intervention Type DRUG

B

Methotrexate

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

Interventions

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Methotrexate

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Parma

OTHER

Sponsor Role lead

Responsible Party

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University of Parma

Principal Investigators

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Carlo Buzio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Parma

Locations

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

Parma, Italy/Parma, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 1739240 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8435284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7906421 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9048352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8602705 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29016646 (View on PubMed)

Other Identifiers

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PCM 01

Identifier Type: -

Identifier Source: org_study_id