NCT00307658TerminatedPhase 3
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
Assistance Publique - Hôpitaux de Paris2 sites in 1 country40 target enrollmentStarted: March 1, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- the remission rate after 9 months of therapy with intravenous immunoglobulins,
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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 Outcomes
- Safety, i.e. side-effects classified according to the WHO guidelines
Investigators
Study Sites (2)
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