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
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