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


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Wegener's Granulomatosis, Churg-Strauss Syndrome, Microscopic Polyangiitis, Polyarteritis Nodosa

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time from remission to relapse

Safety Issue:

No

Principal Investigator

Carlo Buzio, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Parma

Authority:

Italy: Ethics Committee

Study ID:

PCM 01

NCT ID:

NCT00751517

Start Date:

Completion Date:

Related Keywords:

  • Wegener's Granulomatosis
  • Churg-Strauss Syndrome
  • Microscopic Polyangiitis
  • Polyarteritis Nodosa
  • Vasculitis
  • Cyclophosphamide
  • Methotrexate
  • Systemic Necrotizing Vasculitides
  • Churg-Strauss Syndrome
  • Polyarteritis Nodosa
  • Vasculitis
  • Wegener Granulomatosis
  • Systemic Vasculitis
  • Microscopic Polyangiitis

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