Intravenous Immunoglobulin After Relapse in Vasculitis - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00307658

Purpose

The aim of this study is to study the efficacy of intravenous immunoglobulins for inducing remission in patients relapsing of systemic vasculitides.

Condition	Intervention	Phase
ANCA + Vasculitides Relapsing Either Under Corticosteroid and Immunosuppressant Therapies or After One Year Post Treatment.	Drug: Intravenous immunoglobulins (human immunoglobulins G)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Vasculitis Wegener's Granulomatosis

Drug Information available for: Immunoglobulins Corticosteroids Globulin, Immune

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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

Estimated Enrollment:	40
Study Start Date:	March 2001
Estimated Study Completion Date:	July 2006

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307658

Locations

France
Hôpital COCHIN
Paris, France, 75679
Hopital Cochin
Paris, France, 75679

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Loïc GUILLEVIN, MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00307658 History of Changes
Other Study ID Numbers:	P991006
Study First Received:	March 27, 2006
Last Updated:	May 18, 2006
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

ANCA associated Vasculitides
Relapse
intravenous Immunoglobulins
Corticosteroid
Immunosuppressant

Additional relevant MeSH terms:

Vasculitis
Wegener Granulomatosis
Microscopic Polyangiitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Autoimmune Diseases

Immune System Diseases
Immunoglobulin G
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 13, 2012