Documents

RituxME 2014

Description
Rituximab - an update
Categories
Published
of 3
All materials on our website are shared by users. If you have any questions about copyright issues, please report us to resolve them. We are always happy to assist you.
Related Documents
Share
Transcript
  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.
We Need Your Support
Thank you for visiting our website and your interest in our free products and services. We are nonprofit website to share and download documents. To the running of this website, we need your help to support us.

Thanks to everyone for your continued support.

No, Thanks