Intravenous Immunoglobulin After Relapse in Vasculitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2006-07-31

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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Intravenous immunoglobulins (human immunoglobulins G)

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Loïc GUILLEVIN, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital Cochin

Paris, , France

Site Status

Hôpital COCHIN

Paris, , France

Site Status

Countries

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France

References

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Martinez V, Cohen P, Pagnoux C, Vinzio S, Mahr A, Mouthon L, Sailler L, Delaunay C, Sadoun A, Guillevin L; French Vasculitis Study Group. Intravenous immunoglobulins for relapses of systemic vasculitides associated with antineutrophil cytoplasmic autoantibodies: results of a multicenter, prospective, open-label study of twenty-two patients. Arthritis Rheum. 2008 Jan;58(1):308-17. doi: 10.1002/art.23147.

Reference Type DERIVED

PMID: 18163506 (View on PubMed)

Other Identifiers

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P991006

Identifier Type: -

Identifier Source: org_study_id