Study Description: A randomized controlled trial with Rituximab versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDPRIT)
The study’s focus is support for an additional dose of Rituximab after six months of therapy.
Synopsis: In this study, immunoglobulin therapy will be continued for six month after initial rituximab therapy to allow rituximab to become effective. We originally proposed the same protocol shown to be effective in another immunological disease (rheumatoid arthritis) with rituximab at the dose of 1000 mg intravenously versus placebo on day 1 and 15 after randomization. After reconsidering the results of the rituximab trial in arthritis rheumatoid where its efficacy was significant after 24 weeks but declined at week 48, with proposed an amendment to our Ministry of Health to add a further 1 g dose of rituximab or placebo 6 months after the initial therapy, one week after IVIg suspension (see attached revised protocol). This decision took into account the fact that the primary end-point of the study was the different proportion of patients relapsing within 12 months after therapy initiation. This amendment was approved without further financial support for the additional therapy.
Eduardo Nobile-Orazio, MD, PhD, FAAN (Bio)
Associate Professor of Neurology, at Milan University, and is Chair of the Neuromuscular and Neuroimmunology Service at Humanitas Clinical and Research Institute in Rozzano, Milan, Italy
Prof. Nobile-Orazio graduated at Milan University where he obtained his MD degree in 1978, Board in Neurology in 1982, and PhD in Neurological Sciences in 1987. From 1982 to 1984 he attended as Research Fellow the Department of Neurology at Columbia University in New York. In 2001 he was nominated Associate Professor of Neurology at Milan University. He chaired since 2004 the 2nd Neurology and, since 2015, the Neuromuscular and Neuroimmunology Service at Humanitas Clinical and Research Center, Rozzano, Milan, Italy.
Until 2005 he was the co-ordinator of the Italian Peripheral Nerve Study group. From 2011 to 2013 he was President of the Peripheral Nerve Society. He is a member of the Italian Neurological Society, European Academy of Neurology (Member of the Assembly of Delegates), Peripheral Nerve Society (Chair of the Education Committee) and Corresponding Fellow of the American Academy of Neurology and of the American Neurological Association. Since 2013 he is a member of the Medical Advisory Board of GBS-CIDP Foundation International.
He authored over 220 papers mainly devoted to exploring the pathogenesis, diagnosis and treatment of immune-mediated neuropathies and 22 Chapters in Books. He is currently in the Editorial Board Neurological Sciences, Italy, Muscle & Nerve, USA, and Neurology and Clinical Neuroscience, Japan. He was the principal investigator of a randomized trial comparing the efficacy and tolerance of therapy with IVIg or methylprednisolone in CIDP. He is coordinating the study of the Italian CIDP Database and just started coordinating a similar Database on MMN. In 2005 he organized the Meeting of the Peripheral Nerve Society in Tuscany, Italy.