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2016-34: A pilot study towards a therapy with prednisolone encapsulated liposomes for the treatment of Graves’ Orbitopathy with reduced systemic steroid exposure

Orbit and melanoma
Drug research
Investigator Initiated Research
Inclusion stopped on 31-12-2018

The mainstay of treatment for patients with moderate to severe Graves’ Orbitopathy (GO) currently consists of various dose schemes of intravenous (IV) methylprednisolone or high doses oral prednisone. To avoid the frequent and potentially serious adverse effects of such treatment, new immunomodulating therapies are required. In a small study, IV administration of long-circulating liposomal prednisolone (Nanocort, LCLP) has been shown effective in rheumatoid arthritis without causing the typical glucocorticoid-related adverse events (AEs). It is hypothesized that GO can also be effectively treated with LCLP and that the number of AEs will be reduced. This study is performed to demonstrate that Nanocort is safe and effectively reduces the inflammatory signs and symptoms of active GO.

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