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Efficacy of Steroid Versus Steroid Plus Cyclophosphamide for Severe Henoch-Schoenlein Purpura

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ClinicalTrials.gov Identifier: NCT00190229
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 4, 2011
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Henoch-Schonlein purpura is a leucocytoclastic systemic vasculitis involving small vessels with the deposition of immune complexes containing IgA. It is characterized by the association of skin, joint and gastrointestinal manifestations. Even though the evolution is usually simple, some patients, especially adults, may have severe visceral involvement including heart, lung, brain and renal disease. The best treatment is currently unknown. This study will test the safety and efficacy of steroids associated or not with cyclosphosphamide to treat the acute lesions and to prevent the development of chronic lesions.

Condition or disease Intervention/treatment Phase
Henoch-Schoenlein Purpura Drug: Cyclophosphamide Not Applicable

Detailed Description:
The protocol test the role of 2 modalities of treatment (steroid vs. steroid and cyclophosphamide) for severe systemic form of Henoch-Schonlein purpura. The severe forms include extracapillary glomerulonephritis, myocarditis, pneumonitis, occult involvement, severe gastro-intestinal bleeding. No other randomized trial has been performed in adult patient for this indication.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CESAR (Randomized Therapeutic Study of Steroid vs. Steroid Plus Cyclosphosphamide for Severe Viscera Henoch-Schoenlein Purpura)
Study Start Date : September 2002
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasculitis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Cyclophosphamide
Drug: Cyclophosphamide
Cyclophosphamide



Primary Outcome Measures :
  1. Birmingham Vasculitis Activity Score (BVAS) [ Time Frame: during de study ]
    Birmingham Vasculitis Activity Score (BVAS)


Secondary Outcome Measures :
  1. Chronic lesions (Vasculitis Damage Index) [ Time Frame: during the study ]
    Chronic lesions (Vasculitis Damage Index)

  2. Renal function at 12 months [ Time Frame: during the study ]
    Renal function at 12 months

  3. Kidney survival at 12 months [ Time Frame: during the study ]
    Kidney survival at 12 months

  4. Patient survival at 12 months [ Time Frame: during the study ]
    Patient survival at 12 months

  5. Blood pressure [ Time Frame: during th study ]
    Blood pressure

  6. Infections [ Time Frame: during the study ]
    Infections

  7. Adverse events related to steroid or cyclophosphamide [ Time Frame: during the study ]
    Adverse events related to steroid or cyclophosphamide



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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:

  • Patients with Henoch-Schoenlein purpura
  • Patient's age > 18 years

Exclusion criteria:

  • Patient presenting a purpura RHEUMATOID the diagnosis of which is confirmed by the histology presenting at least a visceral infringement(achievement) making consider the affection as engraves(burns)
  • of 18 or more years old Patient
  • Patient capable of understanding(including) the advantages and the risks of the try
  • Patient having given his assent lit in writing

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): NCT00190229


Locations
France
Hôpital LARIBOISIERE
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Eric THERVET, MD Assistance Publique - Hôpitaux de Paris

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amel OUSLIMANI, Department Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00190229     History of Changes
Other Study ID Numbers: P011014
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Vasculitis
Cyclophosphamide
Renal failure

Additional relevant MeSH terms:
Purpura
Purpura, Schoenlein-Henoch
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Immune Complex Diseases
Hypersensitivity
Immune System Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists