Intravenous Immunoglobulin After Relapse in Vasculitis

• Status: Terminated
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to study the efficacy of intravenous immunoglobulins for inducing remission in patients relapsing of systemic vasculitides.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Antibodies; gamma-Globulins; Immunoglobulin G; Immunoglobulins; Immunoglobulins, Intravenous; Immunosuppressive Agents; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Wegener's granulomatosis, Microscopic polyangiitis and Churg-Strauss syndrome (satisfying ACR or chapel Hill classification) relapsing either under corticosteroid and immunosuppressant therapies or after one year post treatment

• Age > 18 years old

• Written informed consent

Exclusion Criteria:

• Systemic vasculitides not previously treated with corticosteroid and immunosuppressant(s)

• Systemic vasculitides treated with corticosteroids and immunosuppressant therapies, but with treatment cessation more than 12 months ago

• Polyarteritis nodosa

• Absence of poor prognosis criteria (according to FFS)

• Nephritis ± renal impairment

• Cancer or malignancy

• Psychiatric disease, lack of compliance

• Age under 18 years old

• Lack of written informed consent

• Other vasculitides (post viral infection and skin localisation)