The Norwegian multicenter Rituximab study begins

The long-awaited Norwegian phase III study of Rituximab as a treatment for ME/CFS is now getting off the ground. The study is led by the oncologists Prof Olav Mella and Dr Øystein Fluge at Haukeland University Hospital in Bergen, Norway. In their previous studies (e g PlosOne 2011 )

Rituximab has had a positive effect in around 2/3 of the ME/CFS patients receiving the active substance. This randomized, double-blind, placebo-controlled phase III study will include 152 patients at five units around Norway. The patients need to fulfill the Canadian Consensus Criteria (CCC) and will be filling in The DePaul Symptom Questionnaire (DSQ) with an added question about whether they are more prone to infection after the ME/CFS onset, or less. Extensive testing will be done before the first infusion. Rituximab will be given week 0 and 2, plus after 3, 6, 9 and 12 months. The patients will then be monitored for another 12 months, so 24 months in total.

A very important part of treatment studies of ME/CFS is objective outcome measures. In this study activity will be registered by Sensewear for 7 consecutive days before and after treatment. At two of the participating units the Stevens Protocol, the 2-day exercise test which has been shown to demonstrate metabolic abnormalities in ME/CFS patients, will be performed. Endothelial function/Flow-Mediated Vasodilatation will be measured at two units, and a sub-study on bowel dysfunction will be performed at the Haukeland unit.

No exact date can be predicted for the completion of the study; it will be completed 24 months after the date when patient no 152 has done the initial testing and been given the first infusion. It will be three years or more before any treatment results can be published.

Prof Olav Mella and Dr Øystein Fluge are also conducting other, small studies of potential medical treatments for ME/CFS. Read more (Norwegian): B-lymfocyttdeplesjon ved bruk av det monoklonale anti-CD20 antistoffet rituximab (Mabthera®) ved myalgisk encefalopati

Studies regarding Rituximab, B cells and autoimmunity in ME/CFS have also been initiated in the UK, thanks to the charity Invest in ME Research. These are being led by Dr Jo Cambridge at University College London, and advisor for these studies is Em Prof Jonathan Edwards. Read more

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