Status:
TERMINATED
Intravenous Immunoglobulin After Relapse in Vasculitis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
ANCA + Vasculitides Relapsing Either Under Corticosteroid
and Immunosuppressant Therapies or After One Year
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 cort...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00307658
Start Date
March 1 2001
End Date
July 1 2006
Last Update
May 22 2006
Active Locations (2)
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1
Hopital Cochin
Paris, France, 75679
2
Hôpital COCHIN
Paris, France, 75679