From the Norwegian ME Association site - ME Research [1] - 3rd July 2013
(loosely translated from the original article by Invest in ME)
There are many who wonder what it takes to participate in the upcoming multi-centre study that Dr Oystein Fluge and Professor Olav Mella will begin in the near future. With regard to this we have obtained the following information that they have encouraged us to share. And we do so with great pleasure. This is the same information that one gets if one contacts the Communications Department at Haukeland hospital.
The information is as follows:
Questions on participation in a research study of Rituximab in ME
Both before and after it became clear that the Research Council of Norway had agreed to part-fund the undersigned to perform a research study with the monoclonal antibody Rituximab in ME, there have been many inquiries concerning participation in this study. All these have been processed and filed. It is important for us to make clear that the Oncology Department does not have the general means to work with ME patients, but does have funding for one study which is designed to determine or disprove whether this drug can, in a significant way, affect the course of the disease in patients suffering from ME according to a stringent clinical definition. At this time the clarification of this scientific question is the most important objective. It is, therefore, of critical importance for this clarification and for understanding of ME as a disease that the correct patients are entered into the study and that this can proceed in a good way in the centres that shall cooperate in the research. The planning phase over the next few months is essential in order for the study to become technically successful.
There have already been two studies performed with Rituximab in ME, but if the treatment is to become an ordinary treatment in the health service, then a new study needs to be performed where the treatment is compared with the effects from a placebo. The study must be performed with a sufficient number of patients to allow the statistical uncertainty to be small and neither patient nor nurse knows which treatment has been given. It is planned to include 140 patients, of which a half will have been seen to have been given a placebo at the end of the two year study.
We and the national ME-centre at Oslo University Hospital have already received clinical information and requests to participate from several hundred patients, but no decision has yet been made for inclusion in the study of any patients. If more patients want to participate in the assessment of participation in the study, then they must send in clinical records to the undersigned or ME-centre of Oslo University Hospital. When the formalities and logistics of the study in the autumn have been arranged, we will start the processing of incoming patient information. Based on this, those patients who best fulfil the criteria for participation in the study will probably receive a questionnaire to be filled out regarding their illness. Patients who are eligible for inclusion will then participate in a selection process. Finally inclusion in the study will, in the meantime, first happen after a clinical examination in one of the centres participating in the study.
Patients who wish to participate in the study can send clinical data of their illness to one of the undersigned or to the ME-centre at Oslo University Hospital. As the study is not an ordinary treatment in the health service, it is an advantage if the information is not sent as an official referral from a doctor to the Institute as this would create more administrative work. Patients who have earlier sent in their information must not do so again as the processing of these requests is time-consuming and requires more from the researchers� time. For the same reasons only patients who are selected for the study will receive a confirmation during the autumn. If all goes as planned, the study is expected to begin in early 2014, probably with participation from five centres in Norway. Patients will preferably obtain treatment from the health region of their residence.
| �ystein Fluge |
Olav Mella |
| Chief Consultant |
Professor Medical Director |
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Address: Kreftavdelingen,
Haukeland Universitetssykehus,
N-5021 Bergen
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