Status:

UNKNOWN

Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides

Lead Sponsor:

University of Parma

Conditions:

Wegener's Granulomatosis

Churg-Strauss Syndrome

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

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 Polyarteriti...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00751517

Last Update

September 12 2008

Active Locations (1)

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1

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

Parma, Italy/Parma, Italy, 43100