RituxME 2014

Rituximab - an update
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  Page 1   Status for RituxME  - multicentre study, on Norwegian ME Association Seminar in Asker, Norway 31 / 10-2 / 11 2014   by Bjørn K Getz Wold   Page 2   RituxME multicentre study: ã Economic status ã Main study ã Sub studies ã Participating Institutions ã Process for selecting patients ã Status report Page 3   Economic status ã Support from the national budget 2012-2015 8 MNOK (million kroner) ã Support from the Norwegian Research Council - 10 million ã Support from MEandYou - 2.8 million ã Support from fundraising: ME Research /Norwegian ME Association - 1.5 million ã Own financial efforts by participating hospitals = Funding secured Page 4   Main study ã Phase III Rituximab-study ã Rituximab / Placebo ã Treatment at 0 and 2 weeks ã Maintenance at 3, 6, 9 and 12 months ã Diagnosis by ICC 2011 criteria ã Self-assessment every 2 weeks ã Sense Wear activity registration before intervention and between 17 and 21 months Page 5   Sub-studies ã Endothelial function in Flow-Mediated Dilation (FMD) in ME/CFS at Haukeland and Notodden. At Haukeland also microvascular function. (Endothelium = thin film on inside of blood vessels). At start-up and between 17.-21. month ã Ergo Spirometry in ME/CFS at Oslo University Hospital, Haukeland and  Notodden. For patients with mild/moderate disease that can manage the test. At start-up and between 17-21 months ã Irritable bowel disease and functional dyspepsia in patients with ME/CFS, Haukeland. For patients with gastrointestinal tract. At start-up and between 17.-21. month Page 6   ã Study Management: Department of Oncology, Haukeland: dr. Olav Mella, Head of Department and Dr Øystein Fluge. National Principal investigator (PI) for clinical trial Olav Mella ã Study Coordinator: Kari Sørland ã Haukeland: PI Øystein Fluge ã OsloUS Medical Clinic OUS Ullevål and CFS / ME Centre, Medical Clinic, OUS-Aker. PI: dr. Katarina Lien ã Notodden, Medical dept: PI dr. Hanne Thürmer ã St Olav's Hospital, Dept of pain and complex symptom disorders: PI Prof. Petter Chr. Borchgrevink ã University Hopsital of North Norway (Tromsø), Department of Physical and rehabilitation medicine: PI Dept. Chief Christoph Schäfer Participating institutions Page 7   Process for selecting patients ã All applications are being reviewed ã A first screening performed ã Potential participants drawn ã These participants convened and then either confirmed in or not ã Refill with new potential patients ã In some hospitals like Notodden, initial investigations for sub-studies ã Rituximab / placebo infusion started at the first study centre on Monday 27 October ã Quarantine: Gamma globulin 3 months, LDN and any other ME medication 1 month Page 8   Status Report as of institution ã Number of participants - Haukeland 40 participants - Oslo: 32 participants - Notodden: 32 participants - St. Olav: 24 participants - UNN Tromsø: 24 participants  ã Haukeland: 31 candidates for questioning, including 10 confirmed. First treatment performed monday, 10/27. ã Notodden: started with screening of patients, including five confirmed. ã OUS: 14 patients screened, two included so far. ã UNN: Screening of patients started this week. Treatment starts after New Year's. ã St. Olav: Screening Calls starting in November. Treatment starts over New Year's. ã Not any of the study centres are done including patients. Candidates are still being convened.
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