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Intravenous Immunoglobulin After Relapse in Vasculitis

This study has been terminated.
Information provided by:
Assistance Publique - Hôpitaux de Paris Identifier:
First received: March 27, 2006
Last updated: May 18, 2006
Last verified: April 2003
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
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:

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00307658

Hopital Cochin
Paris, France, 75679
Hôpital COCHIN
Paris, France, 75679
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Loïc GUILLEVIN, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00307658     History of Changes
Other Study ID Numbers: P991006
Study First Received: March 27, 2006
Last Updated: May 18, 2006

Keywords provided by Assistance Publique - Hôpitaux de Paris:
ANCA associated Vasculitides
intravenous Immunoglobulins

Additional relevant MeSH terms:
Microscopic Polyangiitis
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Autoimmune Diseases
Immune System Diseases
Immunoglobulin G
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017