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

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

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

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)

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Vasculitis

Drug Information available for: Cyclophosphamide

U.S. FDA Resources

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:

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
Study First Received:	September 13, 2005
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00190229 History of Changes
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
Immunologic Factors
Hematologic Diseases
Purpura, Schoenlein-Henoch
Blood Coagulation Disorders
Vascular Diseases
Vasculitis, Hypersensitivity
Cyclophosphamide
Hemostatic Disorders

Immunosuppressive Agents
Signs and Symptoms
Hypersensitivity
Hemorrhagic Disorders
Henoch-Schonlein Purpura
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Kidney Failure

Additional relevant MeSH terms:

Skin Manifestations
Immune Complex Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Vasculitis, Hypersensitivity
Cyclophosphamide
Hemostatic Disorders
Signs and Symptoms
Hypersensitivity
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases

Alkylating Agents
Purpura
Vasculitis
Immune System Diseases
Hematologic Diseases
Blood Coagulation Disorders
Purpura, Schoenlein-Henoch
Vascular Diseases
Immunosuppressive Agents
Pharmacologic Actions
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 02, 2009