Clinical trial NCT00307658: Intravenous Immunoglobulin After Relapse in Vasculitis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2006-03-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: the remission rate after 9 months of therapy with intravenous immunoglobulins,
measure: in relapsing patients with ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome)
measure: during 6 months, after relapse
Secondary outcomes:
measure: Safety, i.e. side-effects classified according to the WHO guidelines
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hôpital COCHIN
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Loïc GUILLEVIN, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez V, Cohen P, Pagnoux C, Vinzio S, Mahr A, Mouthon L, Sailler L, Delaunay C, Sadoun A, Guillevin L; French Vasculitis Study Group. Intravenous immunoglobulins for relapses of systemic vasculitides associated with antineutrophil cytoplasmic autoantibodies: results of a multicenter, prospective, open-label study of twenty-two patients. Arthritis Rheum. 2008 Jan;58(1):308-17. doi: 10.1002/art.23147.