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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00307658

Enrollment

Registered

2006-03-28

Start date

2001-03-31

Completion date

2006-07-31

Last updated

2006-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

ANCA associated Vasculitides, Relapse, intravenous Immunoglobulins, Corticosteroid, Immunosuppressant

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.

Interventions

DRUGIntravenous immunoglobulins (human immunoglobulins G)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Measure	Time frame
Safety, i.e. side-effects classified according to the WHO guidelines	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026