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

Henoch-Schoenlein Purpura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190229
• Other study ID #: P011014
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: May 3, 2011
• Start date: September 2002
• Est. completion date: January 2008

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Henoch-Schoenlein Purpura
• Purpura
• Purpura, Schoenlein-Henoch

Intervention

Drug:
• Cyclophosphamide
Cyclophosphamide

Locations

Country	Name	City	State
France	Hôpital LARIBOISIERE	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Pillebout E, Thervet E, Hill G, Alberti C, Vanhille P, Nochy D. Henoch-Schönlein Purpura in adults: outcome and prognostic factors. J Am Soc Nephrol. 2002 May;13(5):1271-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birmingham Vasculitis Activity Score (BVAS)	Birmingham Vasculitis Activity Score (BVAS)	during de study	Yes
Secondary	Chronic lesions (Vasculitis Damage Index)	Chronic lesions (Vasculitis Damage Index)	during the study	Yes
Secondary	Renal function at 12 months	Renal function at 12 months	during the study	Yes
Secondary	Kidney survival at 12 months	Kidney survival at 12 months	during the study	Yes
Secondary	Patient survival at 12 months	Patient survival at 12 months	during the study	Yes
Secondary	Blood pressure	Blood pressure	during th study	Yes
Secondary	Infections	Infections	during the study	Yes
Secondary	Adverse events related to steroid or cyclophosphamide	Adverse events related to steroid or cyclophosphamide	during the study	Yes