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

Purpose

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

Genetics Home Reference related topics:

hemophilia

MedlinePlus related topics:

Vasculitis

ChemIDplus related topics:

Cyclophosphamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	CESAR (Randomized Therapeutic Study of Steroid vs. Steroid Plus Cyclosphosphamide for Severe Viscera Henoch-Schoenlein Purpura)

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

Primary Outcome Measures:

Birmingham Vasculitis Activity Score (BVAS)
Activity of the disease

Secondary Outcome Measures:

Chronic lesions (Vasculitis Damage Index)
Renal function at 12 months
Kidney survival at 12 months
Patient survival at 12 months
Blood pressure
Infections
Adverse events related to steroid or cyclophosphamide

Estimated Enrollment:	200
Study Start Date:	September 2002
Estimated Study Completion Date:	December 2007

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.

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion criteria:

Patient presenting a purpura rheumatoïd 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications of Results:

Pillebout E, Thervet E, Hill G, Alberti C, Vanhille P, Nochy D. Henoch-Schonlein Purpura in adults: outcome and prognostic factors. J Am Soc Nephrol. 2002 May;13(5):1271-8.

Study ID Numbers:	AOM01034, P011014
First Received:	September 13, 2005
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00190229
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Vasculitis

Cyclophosphamide

Renal failure

Study placed in the following topic categories:

Purpura

Vasculitis

Hematologic Diseases

Purpura, Schoenlein-Henoch

Blood Coagulation Disorders

Vascular Diseases

Vasculitis, Hypersensitivity

Cyclophosphamide

Hemostatic Disorders

Signs and Symptoms

Hypersensitivity

Hemorrhagic Disorders

Henoch-Schonlein purpura

Kidney Failure

Additional relevant MeSH terms:

Skin Manifestations

Immune Complex Diseases

Immune System Diseases

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Therapeutic Uses

Myeloablative Agonists

Cardiovascular Diseases

Antineoplastic Agents, Alkylating

Antirheumatic Agents

Alkylating Agents

ClinicalTrials.gov processed this record on August 21, 2008

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00190229