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

This study has been completed.
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: May 3, 2011
Last verified: March 2007
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 Intervention
Henoch-Schoenlein Purpura
Drug: Cyclophosphamide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CESAR (Randomized Therapeutic Study of Steroid vs. Steroid Plus Cyclosphosphamide for Severe Viscera Henoch-Schoenlein Purpura)

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Birmingham Vasculitis Activity Score (BVAS) [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
    Birmingham Vasculitis Activity Score (BVAS)

Secondary Outcome Measures:
  • Chronic lesions (Vasculitis Damage Index) [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Chronic lesions (Vasculitis Damage Index)

  • Renal function at 12 months [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Renal function at 12 months

  • Kidney survival at 12 months [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Kidney survival at 12 months

  • Patient survival at 12 months [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Patient survival at 12 months

  • Blood pressure [ Time Frame: during th study ] [ Designated as safety issue: Yes ]
    Blood pressure

  • Infections [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

  • Adverse events related to steroid or cyclophosphamide [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Adverse events related to steroid or cyclophosphamide

Enrollment: 200
Study Start Date: September 2002
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Cyclophosphamide

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00190229

Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Eric THERVET, MD Assistance Publique - Hôpitaux de Paris
  More Information

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 
Study First Received: September 13, 2005
Last Updated: May 3, 2011
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 26, 2016