Clinical Trial: Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet`s Disease (INCYTOB)

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase III Study of Recombinant Human Interferon-alpha2a Versus Cyclosporin A for the Treatment of Ocular Behcet`s Disease - a National,Randomised, Single-masked Controlled Trial (INCYTOB)

Brief Summary: The purpose of this study is to investigate if interferon-alpha2a is superior to the standard treatment with cyclosporin A for the treatment of severe ocular manifestations of Behcet`s disease.

Detailed Summary:

Behcet`s disease is a multisystem vasculitis often involving ocular (retinal) blood vessels (in 70% of all cases). This form of uveitis or retinal vasculitis still leads to blindness in 25 to 50% of the patients irrespective of immunosuppressive treatment.

The aim of the study is to evaluate if Interferon-alpha2a is superior to the present standard treatment (cyclosporin A (CSA)) for severe ocular (panuveitis, posterior uveitis, retinal vasculitis) Behçet`s Disease (BD) and significantly improves visual prognosis and quality of health and life of the patients with ocular BD and is acting more rapidly than standard treatment. Furthermore, we want to evaluate if IFN-α induces long term remissions of ocular BD which can be maintained without further medical treatment.

The patients are randomised into two treatment groups (IFN/CSA) and treated for one year according to an algorithm which adapts dosages to clinical course. A crossover from one treatment arm to the other is planned in case of inefficacy.


Sponsor: University Hospital Tuebingen

Current Primary Outcome:

  • Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years) [ Time Frame: 2 years ]
  • Time to improvement and remission [ Time Frame: 2 years ]


Original Primary Outcome:

  • Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 yearss)
  • Time to improvement and remission


Current Secondary Outcome:

  • Laboratory values for inflammatory activity (monthly) [ Time Frame: 2 years ]
  • Number of switches from one treatment to the other [ Time Frame: 2 years ]
  • Quality of life for patients with low vision (monthly) [ Time Frame: 2 years ]
  • Number of ocular and non-ocular relapses (1 year, 2 years) [ Time Frame: 2 years ]
  • Duration of the treatment-free period (second year) [ Time Frame: 2 years ]


Original Secondary Outcome:

  • Laboratory values for inflammatory activity (monthly)
  • Number of switches from one treatment to the other
  • Quality of life for patients with low vision (monthly)
  • Improvement of retinal function (monthly)
  • Number of ocular and non-ocular relapses (1 year, 2 years)
  • Duration of the treatment-free period (second year)


Information By: University Hospital Tuebingen

Dates:
Date Received: September 9, 2005
Date Started: November 2004
Date Completion: December 2012
Last Updated: July 26, 2010
Last Verified: March 2009