Intravenous Immunoglobulin After Relapse in Vasculitis

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

Detailed Description
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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.

Official Title
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Intravenous Immunoglobulin After Relapse in Vasculitis (Microscopic Polyangiitis, Wegener's Granulomatosis and SHURG-STRAUSS Syndrome) During and After Corticosteroids and Immunosuppressant Therapies a Multicenter Prospective Trial

Conditions
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ANCA + Vasculitides Relapsing Either Under Corticosteroid, and Immunosuppressant Therapies or After One Year, Post Treatment.

Intervention / Treatment
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* Drug: Intravenous immunoglobulins (human immunoglobulins G)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravenous immunoglobulins (human immunoglobulins G)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the remission rate after 9 months of therapy with intravenous immunoglobulins, |  |  | 
| in relapsing patients with ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome) |  |  | 
| during 6 months, after relapse |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, i.e. side-effects classified according to the WHO guidelines |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ANCA associated Vasculitides, Relapse, intravenous Immunoglobulins, Corticosteroid, Immunosuppressant