Evaluation of a New Treatment Strategy for Patients With Microscopic Polyangiitis, Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) Without Poor Prognosis Factors (CHUSPAN2)

NCT00647166 Phase 3 COMPLETED

To determine whether a combination of corticosteroids and azathioprine can achieve a higher remission rate and a lower subsequent relapse rate in patients with newly-diagnosed microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) with no poor prognosis factor (FFS=0), and without significantly increasing the rate of adverse events, as compared to corticosteroids alone. The study hypothesis is a reduction of the absolute risk of treatment failure or relapse within the first 24 months following initiation of therapy of least 25%.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	COMPLETED
Enrolment	114
Start date	2008-05
Completion	2015-04

Conditions

• MPA
• PAN or EGPA With FFS=0
• At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids

Interventions

• corticosteroid and azathioprine
• corticosteroid and placebo

Primary outcomes

• combined rate of remission-treatment failures and minor or major relapses at 24 months — 24 months

Countries

France