Intravenous Immunoglobulin After Relapse in Vasculitis

Assistance Publique - Hôpitaux de Paris

Status and phase

Terminated

Phase 3

Conditions

and Immunosuppressant Therapies or After One Year

ANCA + Vasculitides Relapsing Either Under Corticosteroid

Post Treatment.

Treatments

Drug: Intravenous immunoglobulins (human immunoglobulins G)

Study type

Interventional

Funder types

Other

Identifiers

NCT00307658

P991006

Details and patient eligibility

About

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

Full description

The aim of this study will assess the effects of intravenous immunoglobulin in ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome) who relapse under corticosteroid and immunosuppressant therapies or after one year post treatment.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)