Trial intelligence / Profile preview

CHUSPAN: Corticosteroids and Adjunctive Therapy in PAN and MPA

NCT00400075Phase 4

Key facts

Status
Unknown
Start
Jul 1996
Countries
1
Sponsor
Hospices Civils de Lyon
Modality
Small Molecules
Conditions
polyarteritis nodosa (PAN)microscopic polyangiitis (MPA)
01

Overview

Phase 4, randomised trial in polyarteritis nodosa (PAN) and microscopic polyangiitis (MPA) comparing Azathioprine with Cyclophosphamide (2 arms). Primary endpoint: Disease-Free Survival at 5 years. Status: unknown.

02

Design

2 arms
Study design
Randomized
  • Azathioprine

    6 months of oral azathioprine (2mg/kg/day) as adjunctive therapy.

  • Cyclophosphamide

    6 cyclophosphamide pulses (0.6g/m2 D1, D15, D30 then every month) as adjunctive therapy.

03

Who it enrols

Patients >= 15 years with newly diagnosed polyarteritis nodosa or microscopic polyangiitis without poor prognostic factors (FFS=0). Excludes those with prior systemic vasculitis treatment, history of cancer, HIV, HBV, HCV, or psychiatric disorders.

04

Endpoints

Primary

  • Disease-Free Survival

Secondary

  • Overall Survival

  • Relapse Rate

  • Adverse Events

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