Intravenous Immunoglobulin After Relapse in Vasculitis

Phase 3

Terminated

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

• Registration Number: NCT00307658
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2001-03
• Status Verified: 2003-04
• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Study First Posted: 2006-03-28
• Last Update Submitted: 2006-05-18
• Last Update Posted: 2006-05-22
• Study Completion: 2006-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety, i.e. side-effects classified according to the WHO guidelines

Trial Locations

Locations (2)

Hopital Cochin; 🇫🇷 Paris, France

Hôpital COCHIN; 🇫🇷 Paris, France