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Completed

NCT Number: NCT00190229

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

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.

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Key information

Conditions

Henoch-schoenlein Purpura Blood Coagulation Disorders Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Hypersensitivity IgA Vasculitis Immune Complex Diseases Immune System Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Renal Insufficiency Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital LARIBOISIERE

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

Cyclophosphamide

Primary outcomes

  1. Birmingham Vasculitis Activity Score (BVAS)

    Time frame: during de study

    Birmingham Vasculitis Activity Score (BVAS)

Secondary outcomes

  1. Chronic lesions (Vasculitis Damage Index)

    Time frame: during the study

    Chronic lesions (Vasculitis Damage Index)

  2. Renal function at 12 months

    Time frame: during the study

    Renal function at 12 months

  3. Kidney survival at 12 months

    Time frame: during the study

    Kidney survival at 12 months

  4. Patient survival at 12 months

    Time frame: during the study

    Patient survival at 12 months

  5. Blood pressure

    Time frame: during th study

    Blood pressure

  6. Infections

    Time frame: during the study

    Infections

  7. Adverse events related to steroid or cyclophosphamide

    Time frame: during the study

    Adverse events related to steroid or cyclophosphamide

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
May 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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