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Intravenous Immunoglobulin After Relapse in Vasculitis

Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: ANCA + Vasculitides Relapsing Either Under Corticosteroid; and Immunosuppressant Therapies or After One Year; Post Treatment.

Intervention: Intravenous immunoglobulins (human immunoglobulins G) (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Loïc GUILLEVIN, MD,PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris

Summary

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

Clinical Details

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

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: Safety, i.e. side-effects classified according to the WHO guidelines

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Hôpital COCHIN, PARIS 75679, France

Hopital Cochin, PARIS 75679, France

Additional Information

Starting date: March 2001
Ending date: July 2006
Last updated: May 18, 2006

Page last updated: June 20, 2008

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