Behcet's Disease Clinical Trial
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)
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.
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.
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