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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00190229

Collaborator

(none)

200

Enrollment

Location

Arm

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Sep 1, 2002

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Cyclophosphamide

Drug: Cyclophosphamide

Cyclophosphamide

Outcome Measures

Primary Outcome Measures

Birmingham Vasculitis Activity Score (BVAS) [during de study]
Birmingham Vasculitis Activity Score (BVAS)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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