Clinical trial NCT00190229: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Henoch-Schoenlein Purpura
Keywords: Vasculitis
Cyclophosphamide
Renal failure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Birmingham Vasculitis Activity Score (BVAS)
timeFrame: during de study
Secondary outcomes:
measure: Chronic lesions (Vasculitis Damage Index)
timeFrame: during the study
measure: Renal function at 12 months
timeFrame: during the study
measure: Kidney survival at 12 months
timeFrame: during the study
measure: Patient survival at 12 months
timeFrame: during the study
measure: Blood pressure
timeFrame: during th study
measure: Infections
timeFrame: during the study
measure: Adverse events related to steroid or cyclophosphamide
timeFrame: during the study
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital LARIBOISIERE
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Eric THERVET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/01.asn.0000013883.99976.22.
citation: Pillebout E, Alberti C, Guillevin L, Ouslimani A, Thervet E; CESAR study group. Addition of cyclophosphamide to steroids provides no benefit compared with steroids alone in treating adult patients with severe Henoch Schonlein Purpura. Kidney Int. 2010 Sep;78(5):495-502. doi: 10.1038/ki.2010.150. Epub 2010 May 26.