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
  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:


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 April 14, 2014