Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides

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Brief Title

Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides

Official Title

Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Time from remission to relapse

Secondary Outcome

 Recurrence rate

Condition

Wegener's Granulomatosis

Intervention

Methotrexate

Study Arms / Comparison Groups

 A
Description:  Cyclophosphamide

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug





Eligibility 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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Carlo Buzio, MD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT00751517

Organization ID

PCM 01



Study Sponsor

University of Parma


Study Sponsor

Carlo Buzio, MD, Principal Investigator, University of Parma


Verification Date

September 2008