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

Not Applicable

Completed

• Conditions: Henoch-Schoenlein Purpura
• Interventions: Drug: Cyclophosphamide

• Registration Number: NCT00190229
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Status Verified: 2007-03
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Last Update Submitted: 2011-05-03
• Last Update Posted: 2011-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Cyclophosphamide	Cyclophosphamide

Primary Outcome Measures

Name	Time	Method
Birmingham Vasculitis Activity Score (BVAS)	during de study	Birmingham Vasculitis Activity Score (BVAS)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital LARIBOISIERE; 🇫🇷 Paris, France