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Intravenous Immunoglobulin After Relapse in Vasculitis

This study has been terminated.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00307658
First received: March 27, 2006
Last updated: May 18, 2006
Last verified: April 2003
History of Changes
  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 3

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:

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):

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 May 22, 2013