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

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

This study is ongoing, but not recruiting participants.

Study NCT00190229. Last updated on March 13, 2007. Information provided by Assistance Publique - Hôpitaux de Paris

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

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.

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 Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Birmingham Vasculitis Activity Score (BVAS)
Activity of the disease

Secondary Outcome Measure ^†

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

Condition ^†

Henoch-Schoenlein Purpura

Intervention ^†

Drug: Cyclophosphamide

MEDLINE PMIDs

11961015

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

200

Start Date ^†

September 2002

Completion Date

December 2007

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France

Administrative Information Fields

NCT ID ^†

NCT00190229

Organization ID

AOM01034

Secondary IDs ^††

P011014

Study Sponsor ^†

Assistance Publique - Hôpitaux de Paris

Collaborators ^††

Investigators ^†

Principal Investigator:

Eric THERVET, MD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

March 2007

First Received Date ^†

September 13, 2005

Last Updated Date

March 13, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.