Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides

NCT00751517 | Unknown Phase 2

• 1 other identifier: PCM 01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Vasculitis; Cyclophosphamide; Methotrexate; Systemic Necrotizing Vasculitides

Outcome Measures

Primary Outcomes (1)

• Time from remission to relapse

Secondary Outcomes (4)

• Recurrence rate

• Therapy-related toxicity

• Hospitalization rate

• Mortality

Study Arms (2)

A

ACTIVE COMPARATOR

Cyclophosphamide

Drug: Cyclophosphamide

B

EXPERIMENTAL

Methotrexate

Drug: Methotrexate

Interventions

Methotrexate DRUG

B

Cyclophosphamide DRUG

A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of clinically active SNV
• Life-expectancy \> 1 year
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

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

Parma, Italy/Parma, 43100, Italy

Location

Related Publications (6)

• 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.

  PMID: 1739240 BACKGROUND

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

  PMID: 8435284 BACKGROUND

• 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.

  PMID: 7906421 BACKGROUND

• 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.

  PMID: 9048352 BACKGROUND

• 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.

  PMID: 8602705 BACKGROUND

• 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.

  PMID: 29016646 DERIVED

MeSH Terms

Conditions

Granulomatosis with Polyangiitis; Churg-Strauss Syndrome; Microscopic Polyangiitis; Polyarteritis Nodosa; Vasculitis

Interventions

Methotrexate; Cyclophosphamide

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteritis

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Carlo Buzio, MD

  University of Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Last Updated: September 12, 2008

Record last verified: 2008-09

Locations

IT (1)