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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Henoch-Schoenlein Purpura

Intervention / Treatment
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* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cyclophosphamide | Drug: Cyclophosphamide<br>* Cyclophosphamide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birmingham Vasculitis Activity Score (BVAS) | Birmingham Vasculitis Activity Score (BVAS) | during de study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic lesions (Vasculitis Damage Index) | Chronic lesions (Vasculitis Damage Index) | during the study | 
| Renal function at 12 months | Renal function at 12 months | during the study | 
| Kidney survival at 12 months | Kidney survival at 12 months | during the study | 
| Patient survival at 12 months | Patient survival at 12 months | during the study | 
| Blood pressure | Blood pressure | during th study | 
| Infections | Infections | during the study | 
| Adverse events related to steroid or cyclophosphamide | Adverse events related to steroid or cyclophosphamide | during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vasculitis, Cyclophosphamide, Renal failure