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Intravenous Immunoglobulin After Relapse in Vasculitis

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00307658
First Posted: March 28, 2006
Last Update Posted: May 22, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  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
Intervention Model: Single Group Assignment
Masking: None (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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307658


Locations
France
Hopital Cochin
Paris, France, 75679
Hôpital 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00307658     History of Changes
Other Study ID Numbers: P991006
First Submitted: March 27, 2006
First Posted: March 28, 2006
Last Update Posted: May 22, 2006
Last Verified: April 2003

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

Additional relevant MeSH terms:
Recurrence
Vasculitis
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
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunoglobulin G
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs