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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Birmingham Vasculitis Activity Score (BVAS) [ Time Frame: during de study ]

Birmingham Vasculitis Activity Score (BVAS)


Original Primary Outcome:

  • Birmingham Vasculitis Activity Score (BVAS)
  • Activity of the disease


Current Secondary Outcome:

  • Chronic lesions (Vasculitis Damage Index) [ Time Frame: during the study ]
    Chronic lesions (Vasculitis Damage Index)
  • Renal function at 12 months [ Time Frame: during the study ]
    Renal function at 12 months
  • Kidney survival at 12 months [ Time Frame: during the study ]
    Kidney survival at 12 months
  • Patient survival at 12 months [ Time Frame: during the study ]
    Patient survival at 12 months
  • Blood pressure [ Time Frame: during th study ]
    Blood pressure
  • Infections [ Time Frame: during the study ]
    Infections
  • Adverse events related to steroid or cyclophosphamide [ Time Frame: during the study ]
    Adverse events related to steroid or cyclophosphamide


Original Secondary Outcome:

  • Chronic lesions (Vasculitis Damage Index)
  • Renal function at 12 months
  • Kidney survival at 12 months
  • Patient survival at 12 months
  • Blood pressure
  • Infections
  • Adverse events related to steroid or cyclophosphamide


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: September 13, 2005
Date Started: September 2002
Date Completion:
Last Updated: May 3, 2011
Last Verified: March 2007