Back to resultsIntravenous Immunoglobulin After Relapse in Vasculitis
Primary Purpose
ANCA + Vasculitides Relapsing Either Under Corticosteroid, and Immunosuppressant Therapies or After One Year, Post Treatment.
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Intravenous immunoglobulins (human immunoglobulins G)
Sponsored by
About this trial
This is an interventional treatment trial for ANCA + Vasculitides Relapsing Either Under Corticosteroid focused on measuring ANCA associated Vasculitides, Relapse, intravenous Immunoglobulins, Corticosteroid, Immunosuppressant
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)
Sites / Locations
- Hopital Cochin
- Hôpital COCHIN
Outcomes
Primary Outcome Measures
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 Measures
Safety, i.e. side-effects classified according to the WHO guidelines
Full Information
NCT ID
NCT00307658
First Posted
March 27, 2006
Last Updated
May 18, 2006
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00307658
Brief Title
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
2. Study Status
Record Verification Date
April 2003
Overall Recruitment Status
Terminated
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ANCA + Vasculitides Relapsing Either Under Corticosteroid, and Immunosuppressant Therapies or After One Year, Post Treatment.
Keywords
ANCA associated Vasculitides, Relapse, intravenous Immunoglobulins, Corticosteroid, Immunosuppressant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Intravenous immunoglobulins (human immunoglobulins G)
Primary Outcome Measure Information:
Title
the remission rate after 9 months of therapy with intravenous immunoglobulins,
Title
in relapsing patients with ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome)
Title
during 6 months, after relapse
Secondary Outcome Measure Information:
Title
Safety, i.e. side-effects classified according to the WHO guidelines
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loïc GUILLEVIN, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Hôpital COCHIN
City
Paris
ZIP/Postal Code
75679
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
18163506
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.
Results Reference
derived
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Intravenous Immunoglobulin After Relapse in Vasculitis
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