Intravenous Immunoglobulin After Relapse in Vasculitis

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

Sponsors

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Source 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.

Overall Status Terminated
Start Date 2001-03-01
Completion Date 2006-07-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure 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
Measure Time Frame
Safety, i.e. side-effects classified according to the WHO guidelines
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: Intravenous immunoglobulins (human immunoglobulins G)

Eligibility

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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Loïc GUILLEVIN, MD,PhD Principal Investigator Assistance Publique - Hôpitaux de Paris
Location
Facility:
Hopital Cochin | Paris, 75679, France
Hôpital COCHIN | Paris, 75679, France
Location Countries

France

Verification Date

2003-04-01

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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