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Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by University of Parma.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00751517
First Posted: September 12, 2008
Last Update Posted: September 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Parma
  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
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 NLM:


Further study details as provided by University of Parma:

Primary Outcome Measures:
  • Time from remission to relapse

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
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:
Responsible Party: Carlo Buzio, University of Parma
ClinicalTrials.gov Identifier: NCT00751517     History of Changes
Other Study ID Numbers: PCM 01
First Submitted: September 11, 2008
First Posted: September 12, 2008
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:
Vasculitis
Systemic Vasculitis
Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Churg-Strauss Syndrome
Polyarteritis Nodosa
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
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
Skin Diseases, Vascular
Skin Diseases
Cyclophosphamide
Methotrexate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs