Intravenous Immunoglobulin After Relapse in Vasculitis - Tabular View

Tracking Information

First Received Date ^ICMJE

March 27, 2006

Last Updated Date

May 18, 2006

Start Date ^ICMJE

March 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00307658 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety, i.e. side-effects classified according to the WHO guidelines

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Intravenous Immunoglobulin After Relapse in Vasculitis

Official Title ^ICMJE

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

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

ANCA + Vasculitides Relapsing Either Under Corticosteroid
and Immunosuppressant Therapies or After One Year
Post Treatment.

Intervention ^ICMJE

Drug: Intravenous immunoglobulins (human immunoglobulins G)

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00307658

Responsible Party

Study ID Numbers ^ICMJE

P991006

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Loïc GUILLEVIN, MD,PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

April 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP