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:


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
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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:
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:
Microscopic Polyangiitis
Churg-Strauss Syndrome
Polyarteritis Nodosa
Vasculitis
Wegener Granulomatosis
Systemic Vasculitis
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 July 20, 2014